X-Linked Retinitis Pigmentosa
Conditions
Keywords
XLRP, Ophthalmology, Gene Therapy, Retinitis Pigmentosa GTPase Regulator (RPGR), AAV8
Brief summary
The objective of the study is to evaluate the safety, tolerability and efficacy of a single sub-retinal injection of BIIB112 in participants with X-linked retinitis pigmentosa (XLRP).
Detailed description
This study was previously posted by NightstaRx Ltd. In October 2020, sponsorship of the trial was transferred to Biogen.
Interventions
BIOLOGICALBIIB112
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: Part 1: * Participants with genetically confirmed diagnosis of XLRP (with RPGR mutation). * Participant with active disease clinically visible within the macular region in both eyes. Part 2: \- Participant with mean total retinal sensitivity in the study eye as assessed by microperimetry ≥ 0.1 dB and ≤8 dB. Key
Exclusion criteria
Parts 1 and 2: * Participant with history of amblyopia in either eye. * Participated in a gene therapy trial previously or a clinical trial with an investigational drug in the past 12 weeks or received a gene/cell-based therapy at any time previously. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | Up to Month 24 | DLTs are defined as any of the following events considered to be related to study drug: Sustained decrease in best-corrected visual acuity (BCVA) of ≥30 letters on the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart compared to baseline (sustained is defined as lasting 48 hours or more until recovery, with recovery defined as visual acuity (VA) returning to within 10 letters of baseline VA. An exception is made for surgery-related events occurring in close temporal association {within \<24 hours} of the surgery); Vitreous inflammation, vitritis (\>Grade 3 using standardized Nussenblatt vitreous inflammation scale grading); Any clinically significant retinal damage observed that is not directly attributed to complications of surgery; Any clinically relevant suspected unexpected serious adverse reaction, with the exception of vision loss or vision threatening. |
| Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Day 0 (surgery) in Part 1 of the study up to 24 months | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are defined as the AEs starting or worsening on or after the day of the first surgery. |
| Part 2: Percentage of Study Eyes With ≥7 Decibels (dB) Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by Macular Integrity Assessment (MAIA) Microperimetry | Month 12 | MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0', or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Improvement in Retinal Sensitivity in center grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points out of the 16 central points. |
| Part 2: Number of Participants With TEAEs | Day 0 (surgery) in Part 2 of the study up to 12 months | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are defined as AEs starting on or after the day of the first surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline, Months 1, 3, 6, 9, 12, 18, and 24 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. BCVA was reported as number of letters read correctly by the participants using the ETDRS Scale (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Here negative values indicate decline in BCVA. |
| Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Baseline, Months 1, 3, 6, 9, 12, 18, and 24 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. LLVA was reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Here negative values indicate decline in LLVA. |
| Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Months 1, 3, 6, 9, 12, 18, and 24 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters increase from baseline for BCVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Months 1, 3, 6, 9, 12, 18, and 24 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters increase from baseline for LLVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Months 1, 3, 6, 9, 12, 18, and 24 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters increase from baseline for BCVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Months 1, 3, 6, 9, 12, 18, and 24 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters increase from baseline for LLVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Months 1, 3, 6, 9, 12, 18, and 24 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters increase from baseline for BCVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Months 1, 3, 6, 9, 12, 18, and 24 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters increase from baseline for LLVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Months 1, 3, 6, 9, 12, 18, and 24 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters loss from baseline for BCVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Months 1, 3, 6, 9, 12, 18, and 24 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters loss from baseline for LLVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Months 1, 3, 6, 9, 12, 18, and 24 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters loss from baseline for BCVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Months 1, 3, 6, 9, 12, 18, and 24 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters loss from baseline for LLVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Months 1, 3, 6, 9, 12, 18, and 24 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters loss from baseline for BCVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Months 1, 3, 6, 9, 12, 18, and 24 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters loss from baseline for LLVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Months 1, 3, 6, 9, 12, 18, and 24 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Percentage of eyes with a change from baseline of ≥ -5 letters for BCVA were reported for study and non-study eyes. |
| Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Months 1, 3, 6, 9, 12, 18, and 24 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Percentage of eyes with a change from baseline of ≥ -5 letters for LLVA were reported for study and non-study eyes. |
| Part 1: Change From Baseline in Central Ellipsoid Area | Baseline, Months 1, 3, 6, 9, 12, 18, and 24 | Spectral Domain Optical Coherence Tomography (SD-OCT) was used to assess change in central ellipsoid area. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates a decline in central ellipsoid area. |
| Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline, Months 1, 3, 6, 9, 12, 18, and 24 | SD-OCT was used to assess change in central horizontal ellipsoid width. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates a decline in central horizontal ellipsoid width. |
| Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Baseline, Months 1, 3, 6, 9, 12, 18, and 24 | Fundus Autofluoroscence was used to assess the total area of preserved autofluoroscence. Areas of preserved AF were identified as well-demarcated regions of relative hyper autofluorescence (hyper AF) compared with the background areas of surrounding atrophy. A negative change from baseline indicates a decline in total area of preserved autofluoroscence. |
| Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline, Months 1, 3, 6, 9, 12, 18, and 24 | Fundus Autofluoroscence was used to assess the distance from FC to nearest border of preserved autofluoroscence. A negative change from baseline indicates a decline in the total area of preserved autofluoroscence. |
| Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Baseline, Months 6, 12, and 24 | Visual field testing was performed to assess the volume of 30-degree hill vision, reported as dBs. Reliability Factor (RF)=number of false positive responses + number of false negative responses/number of false positive presentations + number of false negative presentations\*100. If there are 0 responses, then RF value=0. RFpositive=number of false positive responses/number of false positive presentations\*100. If RF≤ 20% measurement is considered reliable. If 20% \< RF ≤ 25% and RFpositive ≤ 10% measurement is also considered reliable. Otherwise if 20% \< RF ≤ 25% and RFpositive \> 10%, or RF \> 25%, measurement is not reliable. Only reliable measurements were included for analysis of this outcome measure. Here negative values indicate decline in volume of 30-degree hill vision. |
| Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Baseline, Months 6, 12, and 24 | Visual field testing was performed to assess the volume of full field of hill vision, reported as dBs. RF =number of false positive responses + number of false negative responses/number of false positive presentations + number of false negative presentations\*100. If there are 0 responses, then RF value=0. RFpositive=number of false positive responses/number of false positive presentations\*100. If RF≤ 20% measurement is considered reliable. If 20% \< RF ≤ 25% and RFpositive ≤ 10% measurement is also considered reliable. Otherwise if 20% \< RF ≤ 25% and RFpositive \> 10%, or RF \> 25%, measurement is not reliable. Only reliable measurements were included for analysis of this outcome measure. Here negative values indicate decline in volume of 30-degree hill vision. |
| Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline, Months 3, 6, 12, and 24 | Change in CS was assessed by Pelli-Robson chart which uses a single large letter size (20/60 optotype), with contrast varying across groups of letters. Chart uses letters (6 per line), arranged in groups whose contrast varies from high to low. Participants read the letters, starting with the highest contrast, until they were unable to read two or three letters in a single group. Each group had three letters of the same contrast level, so there were three trials per contrast level. Participant is assigned a score based on the contrast of the last group in which two or three letters were correctly read. Score is a measure of the participant's log contrast sensitivity ranging from 0-2.25, with 0 being no letters read, and 2.25 being all letters read. Total CS score = \[(total letters correct - 3) x 0.05\]. |
| Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Months 1, 2, 3, 6, and 9 | MAIA microperimetry assessment was measured in dBs using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' is assigned a value of '-1' by MAIA in the calculation. Improvement in mean sensitivity in center grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points out of the 16 central points. |
| Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Months 1, 2, 3, 6, 9, and 12 | MAIA microperimetry assessment was measured in dBs using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Improvement in mean sensitivity in whole grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points of the grid as a whole (68 points). |
| Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline, Months 1, 2, 3, 6, 9, and 12 | MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Mean Sensitivity in center grid was defined as the mean in dB of the 16 points located in the center of the grid. Here negative values indicate a decline in retinal sensitivity. |
| Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline, Months 1, 2, 3, 6, 9, and 12 | MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Improvement in mean ensitivity in whole grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points of the grid as a whole (68 points). Here negative values indicate a decline in retinal sensitivity. |
| Part 2: Change From Baseline in BCVA Reported as Letters | Baseline, Months 1, 2, 3, 6, 9, and 12 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. BCVA was reported as number of letters read correctly by the participant, using the ETDRS Scale (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Here negative values indicate a decline in BCVA. |
| Part 2: Change From Baseline in Mean LLVA Reported as Letters | Baseline, Months 1, 3, 6, 9, and 12 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. LLVA was reported as number of letters read correctly by the participant, using the ETDRS Scale (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Here negative values indicate a decline in LLVA. |
| Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Months 1, 2, 3, 6, 9, and 12 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters increase from baseline for BCVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Months 1, 3, 6, 9, and 12 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters increase from baseline for LLVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Months 1, 2, 3, 6, 9, and 12 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Percentage of eyes with a ≥10 letters increase from baseline for BCVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Months 1, 3, 6, 9, and 12 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters increase from baseline for LLVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Months 1, 2, 3, 6, 9, and 12 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters increase from baseline for BCVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Months 1, 3, 6, 9, and 12 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters increase from baseline for LLVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Months 1, 2, 3, 6, 9, and 12 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters loss from baseline for BCVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Months 1, 3, 6, 9, and 12 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters loss from baseline for LLVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Months 1, 2, 3, 6, 9, and 12 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters loss from baseline for BCVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Months 1, 3, 6, 9, and 12 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters loss from baseline for LLVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Months 1, 2, 3, 6, 9, and 12 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters loss from baseline for BCVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Months 1, 3, 6, 9, and 12 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters loss from baseline for LLVA were reported for study and non-study eyes. |
| Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Months 1, 2, 3, 6, 9, and 12 | BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a change from baseline of ≥ -5 letters for BCVA were reported for study and non-study eyes. |
| Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Months 1, 3, 6, 9, 12, 18, and 24 | MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Improvement in Retinal Sensitivity in center grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points out of the 16 central points. |
| Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Baseline, Months 3, 6, and 12 | Visual field testing was performed to assess the volume of 30-degree hill vision, reported as dBs. RF=number of false positive responses + number of false negative responses/number of false positive presentations + number of false negative presentations\*100. If there are 0 responses, then RF value=0. RFpositive=number of false positive responses/number of false positive presentations\*100. If RF≤ 20% measurement is considered reliable. If 20% \< RF ≤ 25% and RFpositive ≤ 10% measurement is also considered reliable. Otherwise if 20% \< RF ≤ 25% and RFpositive \> 10%, or RF \> 25%, measurement is not reliable. Only reliable measurements were included for analysis of this outcome measure. Here negative values indicate decline in the volume of 30-degree hill vision. |
| Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Baseline, Months 3, 6, and 12 | Visual field testing was performed to assess the volume of full field of hill vision, reported as dBs. RF=number of false positive responses + number of false negative responses/number of false positive presentations + number of false negative presentations\*100. If there are 0 responses, then RF value=0. RFpositive=number of false positive responses/number of false positive presentations\*100. If RF≤ 20% measurement is considered reliable. If 20% \< RF ≤ 25% and RFpositive ≤ 10% measurement is also considered reliable. Otherwise if 20% \< RF ≤ 25% and RFpositive \> 10%, or RF \> 25%, measurement is not reliable. Only reliable measurements were included for analysis of this outcome measure. Here negative values indicate decline in volume of full field hill vision. |
| Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Months 1, 3, 6, 9, and 12 | LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a change from baseline of ≥ -5 letters for LLVA were reported for study and non-study eyes. |
| Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Months 1, 3, 6, 9, 12, 18, and 24 | MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Improvement in Retinal Sensitivity in whole grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points of the grid as a whole (68 points). |
| Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline, Months 1, 3, 6, 9, 12, 18, and 24 | MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' is assigned a value of '-1' by MAIA in the calculation. Improvement in mean sensitivity in center grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points out of the 16 central points. Here negative values indicate a decline in retinal sensitivity. |
| Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline, Months 1, 3, 6, 9, 12, 18, and 24 | MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' is assigned a value of '-1' by MAIA in the calculation. Improvement in mean sensitivity in whole grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points of the grid as a whole (68 points). Here negative values indicate a decline in retinal sensitivity. |
Countries
United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled at investigational sites in the United Kingdom (UK) and the United States (US) from 08 March 2017 to 18 November 2020.
Pre-assignment details
A total of 50 participants with X-Linked Retinitis Pigmentosa (XLRP) were enrolled in the study (18 participants in Part 1 and 32 participants in Part 2). Of these, 47 participants completed the study (18 participants in Part 1 and 29 in Part 2).
Participants by arm
| Arm | Count |
|---|---|
| Part 1: BIIB112 Dose 1 Followed by vitrectomy and retinal detachment in the study eye, participants received a single dose 1 (5 × 10\^9 vg) of BIIB112 by sub-retinal injection on Day 0 (surgery day). | 3 |
| Part 1: BIIB112 Dose 2 Followed by vitrectomy and retinal detachment in the study eye, participants received a single dose 2 (1 × 10\^10 vg) of BIIB112 by sub-retinal injection on Day 0 (surgery day). | 3 |
| Part 1: BIIB112 Dose 3 Followed by vitrectomy and retinal detachment in the study eye, participants received a single dose 3 (5 × 10\^10 vg) of BIIB112 by sub-retinal injection on Day 0 (surgery day). | 3 |
| Part 1: BIIB112 Dose 4 Followed by vitrectomy and retinal detachment in the study eye, participants received a single dose 4 (1 × 10\^11 vg) of BIIB112 by sub-retinal injection on Day 0 (surgery day). | 3 |
| Part 1: BIIB112 Dose 5 Followed by vitrectomy and retinal detachment in the study eye, participants received a single dose 5 (2.5 × 10\^11 vg) of BIIB112 by sub-retinal injection on Day 0 (surgery day). | 3 |
| Part 1: BIIB112 Dose 6 Followed by vitrectomy and retinal detachment in the study eye, participants received a single dose 6 (5 × 10\^11 vg) of BIIB112 by sub-retinal injection on Day 0 (surgery day). | 3 |
| Part 2: Untreated Group Participants received no intervention to allow for a controlled comparison. | 9 |
| Part 2: BIIB112 Low Dose Followed by vitrectomy and retinal detachment in study eye, participants received a single low dose (5 × 10\^10 vg) of BIIB112 by sub-retinal injection on Day 0 (surgery day). | 11 |
| Part 2: BIIB112 High Dose Followed by vitrectomy and retinal detachment in study eye, participants received a single high dose (2.5 × 10\^11 vg) of BIIB112 by sub-retinal injection on Day 0 (surgery day). | 12 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Part 2 (Month 25 up to Month 36) | Withdrew due to Coronavirus 2019COVID-19 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Part 1: BIIB112 Dose 1 | Part 1: BIIB112 Dose 2 | Part 1: BIIB112 Dose 3 | Part 1: BIIB112 Dose 4 | Part 1: BIIB112 Dose 5 | Part 1: BIIB112 Dose 6 | Part 2: Untreated Group | Part 2: BIIB112 Low Dose | Part 2: BIIB112 High Dose | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 36.3 years STANDARD_DEVIATION 6.35 | 34.3 years STANDARD_DEVIATION 10.69 | 30.0 years STANDARD_DEVIATION 2.65 | 33.3 years STANDARD_DEVIATION 14.57 | 25.0 years STANDARD_DEVIATION 5 | 32.3 years STANDARD_DEVIATION 15.31 | 33.7 years STANDARD_DEVIATION 13.83 | 30.6 years STANDARD_DEVIATION 8.83 | 26.8 years STANDARD_DEVIATION 7.11 | 30.7 years STANDARD_DEVIATION 9.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 5 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 2 Participants | 7 Participants | 8 Participants | 7 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race White | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 6 Participants | 9 Participants | 12 Participants | 45 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 9 Participants | 11 Participants | 12 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 9 | 0 / 11 | 0 / 12 |
| other Total, other adverse events | 3 / 3 | 3 / 3 | 3 / 3 | 3 / 3 | 3 / 3 | 3 / 3 | 5 / 9 | 11 / 11 | 12 / 12 |
| serious Total, serious adverse events | 1 / 3 | 1 / 3 | 0 / 3 | 0 / 3 | 1 / 3 | 2 / 3 | 1 / 9 | 3 / 11 | 5 / 12 |
Outcome results
Primary
Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs)
DLTs are defined as any of the following events considered to be related to study drug: Sustained decrease in best-corrected visual acuity (BCVA) of ≥30 letters on the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart compared to baseline (sustained is defined as lasting 48 hours or more until recovery, with recovery defined as visual acuity (VA) returning to within 10 letters of baseline VA. An exception is made for surgery-related events occurring in close temporal association {within \<24 hours} of the surgery); Vitreous inflammation, vitritis (\>Grade 3 using standardized Nussenblatt vitreous inflammation scale grading); Any clinically significant retinal damage observed that is not directly attributed to complications of surgery; Any clinically relevant suspected unexpected serious adverse reaction, with the exception of vision loss or vision threatening.
Time frame: Up to Month 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: BIIB112 Dose 2 | Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: BIIB112 Dose 3 | Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: BIIB112 Dose 4 | Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: BIIB112 Dose 5 | Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
| Part 1: BIIB112 Dose 6 | Part 1: Number of Participants With Dose-Limiting Toxicities (DLTs) | 0 Participants |
Primary
Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are defined as the AEs starting or worsening on or after the day of the first surgery.
Time frame: Day 0 (surgery) in Part 1 of the study up to 24 months
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 3 Participants |
| Part 1: BIIB112 Dose 2 | Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 3 Participants |
| Part 1: BIIB112 Dose 3 | Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 3 Participants |
| Part 1: BIIB112 Dose 4 | Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 3 Participants |
| Part 1: BIIB112 Dose 5 | Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 3 Participants |
| Part 1: BIIB112 Dose 6 | Part 1: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 3 Participants |
Primary
Part 2: Number of Participants With TEAEs
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are defined as AEs starting on or after the day of the first surgery.
Time frame: Day 0 (surgery) in Part 2 of the study up to 12 months
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Number of Participants With TEAEs | 5 Participants |
| Part 1: BIIB112 Dose 2 | Part 2: Number of Participants With TEAEs | 11 Participants |
| Part 1: BIIB112 Dose 3 | Part 2: Number of Participants With TEAEs | 12 Participants |
Primary
Part 2: Percentage of Study Eyes With ≥7 Decibels (dB) Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by Macular Integrity Assessment (MAIA) Microperimetry
MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0', or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Improvement in Retinal Sensitivity in center grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points out of the 16 central points.
Time frame: Month 12
Population: Intent-to-treat (ITT) analysis set included all participants that were randomized under the 3-arm randomization schedules. Overall number of participants analyzed signifies the number of participants with data available for analysis of this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 Decibels (dB) Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by Macular Integrity Assessment (MAIA) Microperimetry | 22.2 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 Decibels (dB) Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by Macular Integrity Assessment (MAIA) Microperimetry | 37.5 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 Decibels (dB) Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by Macular Integrity Assessment (MAIA) Microperimetry | 25.0 percentage of study eyes |
p-value: =0.3181Fisher's Exact-Boschloo test
p-value: =0.5177Fisher's Exact-Boschloo test
Secondary
Part 1: Change From Baseline in Central Ellipsoid Area
Spectral Domain Optical Coherence Tomography (SD-OCT) was used to assess change in central ellipsoid area. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates a decline in central ellipsoid area.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Study Eye | -0.100 square millimeters (mm^2) | Standard Deviation 0.1249 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Study Eye | 0.140 square millimeters (mm^2) | Standard Deviation 0.1637 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Study Eye | -0.077 square millimeters (mm^2) | Standard Deviation 0.1159 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Non-Study Eye | -0.060 square millimeters (mm^2) | Standard Deviation 0.0265 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Non-Study Eye | 0.130 square millimeters (mm^2) | Standard Deviation 0.0985 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Non-Study Eye | -0.093 square millimeters (mm^2) | Standard Deviation 0.0404 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Study Eye | -0.120 square millimeters (mm^2) | Standard Deviation 0.1375 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Non-Study Eye | -0.093 square millimeters (mm^2) | Standard Deviation 0.0404 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Study Eye | -0.127 square millimeters (mm^2) | Standard Deviation 0.1419 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Non-Study Eye | -0.097 square millimeters (mm^2) | Standard Deviation 0.0451 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Study Eye | -0.130 square millimeters (mm^2) | Standard Deviation 0.1473 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Non-Study Eye | -0.097 square millimeters (mm^2) | Standard Deviation 0.0451 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Study Eye | -0.133 square millimeters (mm^2) | Standard Deviation 0.1528 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Non-Study Eye | 0.1528 square millimeters (mm^2) | Standard Deviation 0.0709 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Study Eye | -0.133 square millimeters (mm^2) | Standard Deviation 0.1528 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Non-Study Eye | -0.117 square millimeters (mm^2) | Standard Deviation 0.0764 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Non-Study Eye | -0.383 square millimeters (mm^2) | Standard Deviation 0.4508 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Study Eye | -0.540 square millimeters (mm^2) | Standard Deviation 0.9353 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Non-Study Eye | -0.410 square millimeters (mm^2) | Standard Deviation 0.4951 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Study Eye | -0.527 square millimeters (mm^2) | Standard Deviation 0.9122 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Study Eye | -0.493 square millimeters (mm^2) | Standard Deviation 0.8545 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Non-Study Eye | 2.313 square millimeters (mm^2) | Standard Deviation 3.75 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Non-Study Eye | -0.450 square millimeters (mm^2) | Standard Deviation 0.5408 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Study Eye | -0.567 square millimeters (mm^2) | Standard Deviation 0.9815 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Non-Study Eye | -0.447 square millimeters (mm^2) | Standard Deviation 0.5353 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Study Eye | -0.560 square millimeters (mm^2) | Standard Deviation 0.9699 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Study Eye | 2.750 square millimeters (mm^2) | Standard Deviation 4.7631 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Non-Study Eye | -0.443 square millimeters (mm^2) | Standard Deviation 0.5297 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Study Eye | -0.560 square millimeters (mm^2) | Standard Deviation 0.9699 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Non-Study Eye | -0.437 square millimeters (mm^2) | Standard Deviation 0.5326 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Study Eye | -0.573 square millimeters (mm^2) | Standard Deviation 0.993 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Non-Study Eye | -0.407 square millimeters (mm^2) | Standard Deviation 0.4895 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Study Eye | -0.137 square millimeters (mm^2) | Standard Deviation 0.1582 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Non-Study Eye | -0.020 square millimeters (mm^2) | Standard Deviation 0.0693 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Study Eye | -0.110 square millimeters (mm^2) | Standard Deviation 0.1153 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Non-Study Eye | -0.043 square millimeters (mm^2) | Standard Deviation 0.0379 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Study Eye | -0.113 square millimeters (mm^2) | Standard Deviation 0.1206 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Non-Study Eye | -0.060 square millimeters (mm^2) | Standard Deviation 0.0529 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Study Eye | -0.117 square millimeters (mm^2) | Standard Deviation 0.1258 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Non-Study Eye | -0.063 square millimeters (mm^2) | Standard Deviation 0.0569 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Study Eye | -0.117 square millimeters (mm^2) | Standard Deviation 0.1258 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Non-Study Eye | -0.033 square millimeters (mm^2) | Standard Deviation 0.1266 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Non-Study Eye | -0.060 square millimeters (mm^2) | Standard Deviation 0.0794 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Study Eye | -0.137 square millimeters (mm^2) | Standard Deviation 0.1582 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Non-Study Eye | -0.027 square millimeters (mm^2) | Standard Deviation 0.1201 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Study Eye | 0.137 square millimeters (mm^2) | Standard Deviation 0.1582 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Non-Study Eye | 0.093 square millimeters (mm^2) | Standard Deviation 0.0814 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Study Eye | -0.103 square millimeters (mm^2) | Standard Deviation 0.105 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Non-Study Eye | -0.115 square millimeters (mm^2) | Standard Deviation 0.0919 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Study Eye | -0.063 square millimeters (mm^2) | Standard Deviation 0.0551 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Study Eye | -0.060 square millimeters (mm^2) | Standard Deviation 0.0529 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Study Eye | -0.053 square millimeters (mm^2) | Standard Deviation 0.0551 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Non-Study Eye | 0.465 square millimeters (mm^2) | Standard Deviation 0.1061 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Non-Study Eye | -0.120 square millimeters (mm^2) | Standard Deviation 0.0424 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Study Eye | 0.010 square millimeters (mm^2) | Standard Deviation 0.1552 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Non-Study Eye | -0.080 square millimeters (mm^2) | Standard Deviation 0.0566 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Study Eye | 0.193 square millimeters (mm^2) | Standard Deviation 0.1686 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Non-Study Eye | -0.120 square millimeters (mm^2) | Standard Deviation 0.0141 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Non-Study Eye | -0.120 square millimeters (mm^2) | Standard Deviation 0.0424 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Study Eye | 0.027 square millimeters (mm^2) | Standard Deviation 0.1617 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Study Eye | -0.050 square millimeters (mm^2) | Standard Deviation 0.0458 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Non-Study Eye | -0.095 square millimeters (mm^2) | Standard Deviation 0.0495 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Non-Study Eye | -0.150 square millimeters (mm^2) | Standard Deviation 0.0283 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Study Eye | -0.070 square millimeters (mm^2) | Standard Deviation 0.0624 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Non-Study Eye | -0.410 square millimeters (mm^2) | Standard Deviation 0.7645 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Study Eye | 8.327 square millimeters (mm^2) | Standard Deviation 13.86 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Study Eye | -1.360 square millimeters (mm^2) | Standard Deviation 2.2863 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Study Eye | -2.255 square millimeters (mm^2) | Standard Deviation 3.0335 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Study Eye | -4.847 square millimeters (mm^2) | Standard Deviation 8.1176 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Non-Study Eye | -0.407 square millimeters (mm^2) | Standard Deviation 0.7778 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Non-Study Eye | -0.983 square millimeters (mm^2) | Standard Deviation 1.7747 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Study Eye | -5.657 square millimeters (mm^2) | Standard Deviation 9.5292 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Study Eye | -5.623 square millimeters (mm^2) | Standard Deviation 9.4975 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Non-Study Eye | -1.163 square millimeters (mm^2) | Standard Deviation 2.0063 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Non-Study Eye | -1.010 square millimeters (mm^2) | Standard Deviation 2.0313 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Study Eye | -5.640 square millimeters (mm^2) | Standard Deviation 9.483 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Non-Study Eye | 14.307 square millimeters (mm^2) | Standard Deviation 24.1914 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Non-Study Eye | -1.100 square millimeters (mm^2) | Standard Deviation 1.9504 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Study Eye | -5.633 square millimeters (mm^2) | Standard Deviation 9.4975 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Non-Study Eye | -1.107 square millimeters (mm^2) | Standard Deviation 2.0124 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Non-Study Eye | -0.050 square millimeters (mm^2) | Standard Deviation 0.0707 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Study Eye | -2.960 square millimeters (mm^2) | Standard Deviation 5.0664 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Study Eye | -3.010 square millimeters (mm^2) | Standard Deviation 5.1357 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Study Eye | -2.960 square millimeters (mm^2) | Standard Deviation 5.0319 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Study Eye | 3.107 square millimeters (mm^2) | Standard Deviation 5.2001 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 9: Non-Study Eye | -0.050 square millimeters (mm^2) | Standard Deviation 0.0707 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 24: Non-Study Eye | 0.367 square millimeters (mm^2) | Standard Deviation 0.7505 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Study Eye | -3.007 square millimeters (mm^2) | Standard Deviation 5.1386 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 12: Non-Study Eye | 0.997 square millimeters (mm^2) | Standard Deviation 1.8312 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Non-Study Eye | 0.873 square millimeters (mm^2) | Standard Deviation 1.5824 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Baseline: Non-Study Eye | 5.257 square millimeters (mm^2) | Standard Deviation 8.872 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Study Eye | -2.993 square millimeters (mm^2) | Standard Deviation 5.1155 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 18: Non-Study Eye | 0.590 square millimeters (mm^2) | Standard Deviation 1.1364 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 3: Non-Study Eye | -0.040 square millimeters (mm^2) | Standard Deviation 0.0566 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 1: Study Eye | -1.310 square millimeters (mm^2) | Standard Deviation 2.2258 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Ellipsoid Area | Change From Baseline at Month 6: Study Eye | -0.055 square millimeters (mm^2) | Standard Deviation 0.0778 |
Secondary
Part 1: Change From Baseline in Central Horizontal Ellipsoid Width
SD-OCT was used to assess change in central horizontal ellipsoid width. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates a decline in central horizontal ellipsoid width.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Study Eye | -73.00 Microns | Standard Deviation 70.193 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Study Eye | 162.67 Microns | Standard Deviation 175.104 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Non-Study Eye | 355.67 Microns | Standard Deviation 378 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Study Eye | -56.33 Microns | Standard Deviation 73.894 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Non-Study Eye | -62.33 Microns | Standard Deviation 40.216 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Non-Study Eye | -149.00 Microns | Standard Deviation 80.988 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Study Eye | -115.67 Microns | Standard Deviation 105.624 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Non-Study Eye | -158.67 Microns | Standard Deviation 65.033 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Study Eye | -127.00 Microns | Standard Deviation 121.025 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Non-Study Eye | -175.00 Microns | Standard Deviation 39.585 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Study Eye | -130.00 Microns | Standard Deviation 125.3 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Non-Study Eye | -181.67 Microns | Standard Deviation 30.665 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Study Eye | -131.00 Microns | Standard Deviation 126.74 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Non-Study Eye | -316.67 Microns | Standard Deviation 213.601 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Study Eye | -131.33 Microns | Standard Deviation 127.222 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Non-Study Eye | -329.33 Microns | Standard Deviation 235.434 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Non-Study Eye | -321.67 Microns | Standard Deviation 557.143 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Study Eye | -321.33 Microns | Standard Deviation 556.566 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Non-Study Eye | -347.00 Microns | Standard Deviation 601.022 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Study Eye | -318.67 Microns | Standard Deviation 551.947 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Study Eye | -311.00 Microns | Standard Deviation 538.668 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Study Eye | 1375.33 Microns | Standard Deviation 2382.147 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Non-Study Eye | -354.67 Microns | Standard Deviation 614.301 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Study Eye | -239.33 Microns | Standard Deviation 414.537 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Non-Study Eye | -349.33 Microns | Standard Deviation 605.063 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Study Eye | -318.00 Microns | Standard Deviation 550.792 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Non-Study Eye | 1383.67 Microns | Standard Deviation 396.581 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Non-Study Eye | -358.00 Microns | Standard Deviation 620.074 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Study Eye | -238.33 Microns | Standard Deviation 412.805 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Non-Study Eye | -348.00 Microns | Standard Deviation 602.754 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Study Eye | -242.33 Microns | Standard Deviation 419.734 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Non-Study Eye | -333.33 Microns | Standard Deviation 577.35 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Study Eye | -248.00 Microns | Standard Deviation 275.158 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Non-Study Eye | 47.33 Microns | Standard Deviation 226.509 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Study Eye | -174.33 Microns | Standard Deviation 163.022 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Non-Study Eye | -60.67 Microns | Standard Deviation 78.258 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Study Eye | -175.67 Microns | Standard Deviation 164.852 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Non-Study Eye | -76.33 Microns | Standard Deviation 79.135 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Study Eye | -178.33 Microns | Standard Deviation 168.548 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Non-Study Eye | -77.33 Microns | Standard Deviation 79.053 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Study Eye | -217.00 Microns | Standard Deviation 225.98 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Non-Study Eye | -35.67 Microns | Standard Deviation 255.895 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Non-Study Eye | -145.67 Microns | Standard Deviation 162.543 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Study Eye | -248.00 Microns | Standard Deviation 275.158 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Non-Study Eye | -168.67 Microns | Standard Deviation 161.122 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Study Eye | 248.00 Microns | Standard Deviation 275.158 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Non-Study Eye | 250.00 Microns | Standard Deviation 33.139 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Study Eye | -174.00 Microns | Standard Deviation 162.567 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Non-Study Eye | -188.00 Microns | Standard Deviation 65.054 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Study Eye | -26.33 Microns | Standard Deviation 24.007 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Study Eye | -89.33 Microns | Standard Deviation 125.644 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Study Eye | 462.33 Microns | Standard Deviation 400.775 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Non-Study Eye | 792.00 Microns | Standard Deviation 300.409 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Non-Study Eye | -113.50 Microns | Standard Deviation 47.376 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Study Eye | -43.33 Microns | Standard Deviation 243.904 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Study Eye | -149.00 Microns | Standard Deviation 131.936 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Non-Study Eye | -56.00 Microns | Standard Deviation 63.64 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Study Eye | -106.33 Microns | Standard Deviation 132.666 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Non-Study Eye | -202.50 Microns | Standard Deviation 4.95 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Study Eye | 21.67 Microns | Standard Deviation 332.031 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Non-Study Eye | -195.50 Microns | Standard Deviation 6.364 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Non-Study Eye | -151.00 Microns | Standard Deviation 15.556 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Non-Study Eye | -254.50 Microns | Standard Deviation 7.778 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Study Eye | -146.67 Microns | Standard Deviation 129.454 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Non-Study Eye | -14.00 Microns | Standard Deviation 113.331 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Study Eye | 4556.473 Microns | Standard Deviation 248.605 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Study Eye | -369.00 Microns | Standard Deviation 271.07 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Study Eye | 2411.33 Microns | Standard Deviation 3048.253 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Study Eye | -1070.67 Microns | Standard Deviation 1365.685 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Non-Study Eye | -19.00 Microns | Standard Deviation 123.503 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Non-Study Eye | -20.00 Microns | Standard Deviation 144.503 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Study Eye | -1162.00 Microns | Standard Deviation 1352.05 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Study Eye | -1055.33 Microns | Standard Deviation 1394.128 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Non-Study Eye | -113.00 Microns | Standard Deviation 242.736 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Non-Study Eye | -143.00 Microns | Standard Deviation 221.007 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Non-Study Eye | 3341.00 Microns | Standard Deviation 4556.473 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Non-Study Eye | -159.67 Microns | Standard Deviation 265.038 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Study Eye | -1059.67 Microns | Standard Deviation 1438.362 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Non-Study Eye | -81.67 Microns | Standard Deviation 217.721 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Study Eye | -1096.33 Microns | Standard Deviation 1343.289 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Non-Study Eye | -108.50 Microns | Standard Deviation 153.442 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Study Eye | -441.00 Microns | Standard Deviation 505.72 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Study Eye | -465.67 Microns | Standard Deviation 587.699 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Study Eye | -453.33 Microns | Standard Deviation 554.795 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 9: Non-Study Eye | -124.00 Microns | Standard Deviation 175.362 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 24: Non-Study Eye | 1065.67 Microns | Standard Deviation 2074.136 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Study Eye | -463.00 Microns | Standard Deviation 537.199 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 12: Non-Study Eye | 1108.00 Microns | Standard Deviation 2145.532 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Non-Study Eye | 977.33 Microns | Standard Deviation 1814.5 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Non-Study Eye | 937.67 Microns | Standard Deviation 1088.262 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Study Eye | -461.67 Microns | Standard Deviation 530.381 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 18: Non-Study Eye | 1078.67 Microns | Standard Deviation 2094.819 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 1: Study Eye | 88.67 Microns | Standard Deviation 422.044 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 3: Non-Study Eye | 1008.33 Microns | Standard Deviation 1869.924 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Change From Baseline at Month 6: Study Eye | -461.33 Microns | Standard Deviation 553.453 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Central Horizontal Ellipsoid Width | Baseline: Study Eye | 745.67 Microns | Standard Deviation 774.448 |
Secondary
Part 1: Change From Baseline in Contrast Sensitivity (CS) Score
Change in CS was assessed by Pelli-Robson chart which uses a single large letter size (20/60 optotype), with contrast varying across groups of letters. Chart uses letters (6 per line), arranged in groups whose contrast varies from high to low. Participants read the letters, starting with the highest contrast, until they were unable to read two or three letters in a single group. Each group had three letters of the same contrast level, so there were three trials per contrast level. Participant is assigned a score based on the contrast of the last group in which two or three letters were correctly read. Score is a measure of the participant's log contrast sensitivity ranging from 0-2.25, with 0 being no letters read, and 2.25 being all letters read. Total CS score = \[(total letters correct - 3) x 0.05\].
Time frame: Baseline, Months 3, 6, 12, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Non-Study Eye | 0.000 Score on scale | Standard Deviation 0 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Study Eye | 0.167 Score on scale | Standard Deviation 0.1528 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Non-Study Eye | -0.183 Score on scale | Standard Deviation 0.1258 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Study Eye | 0.000 Score on scale | Standard Deviation 0.2291 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Non-Study Eye | -0.100 Score on scale | Standard Deviation 0.2828 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Study Eye | 0.100 Score on scale | Standard Deviation 0.2828 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Non-Study | 0.433 Score on scale | Standard Deviation 0.2082 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Study Eye | 0.300 Score on scale | Standard Deviation 0.1732 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Non-Study Eye | 0.000 Score on scale | Standard Deviation 0.1732 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Study Eye | 0.133 Score on scale | Standard Deviation 0.2082 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Non-Study | 0.583 Score on scale | Standard Deviation 0.2255 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Study Eye | 0.533 Score on scale | Standard Deviation 0.2309 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Study Eye | 0.183 Score on scale | Standard Deviation 0.2566 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Non-Study Eye | 0.017 Score on scale | Standard Deviation 0.401 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Study Eye | 0.067 Score on scale | Standard Deviation 0.2363 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Non-Study Eye | 0.033 Score on scale | Standard Deviation 0.2255 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Study Eye | 0.133 Score on scale | Standard Deviation 0.3512 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Non-Study Eye | 0.067 Score on scale | Standard Deviation 0.3512 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Study Eye | 0.017 Score on scale | Standard Deviation 0.5965 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Non-Study Eye | 0.117 Score on scale | Standard Deviation 0.3884 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Non-Study Eye | 0.050 Score on scale | Standard Deviation 0.05 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Non-Study Eye | 0.000 Score on scale | Standard Deviation 0 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Study Eye | 0.900 Score on scale | Standard Deviation 0.1732 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Study Eye | 0.100 Score on scale | Standard Deviation 0.1323 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Study Eye | 0.150 Score on scale | Standard Deviation 0.0866 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Non-Study | 1.050 Score on scale | Standard Deviation 0.2598 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Non-Study Eye | 0.083 Score on scale | Standard Deviation 0.0764 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Study Eye | -0.100 Score on scale | Standard Deviation 0 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Non-Study Eye | -0.100 Score on scale | Standard Deviation 0.1732 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Study Eye | -0.017 Score on scale | Standard Deviation 0.1041 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Study Eye | 0.183 Score on scale | Standard Deviation 0.0577 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Non-Study Eye | 0.000 Score on scale | Standard Deviation 0.05 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Non-Study | 0.933 Score on scale | Standard Deviation 0.4646 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Non-Study Eye | 0.017 Score on scale | Standard Deviation 0.2021 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Study Eye | 0.217 Score on scale | Standard Deviation 0.1893 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Study Eye | 0.883 Score on scale | Standard Deviation 0.3884 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Non-Study Eye | 0.050 Score on scale | Standard Deviation 0.1 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Study Eye | 0.133 Score on scale | Standard Deviation 0.0577 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Non-Study Eye | 0.050 Score on scale | Standard Deviation 0.05 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Study Eye | 0.133 Score on scale | Standard Deviation 0.1155 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Study Eye | -0.167 Score on scale | Standard Deviation 0.6788 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Non-Study Eye | 0.100 Score on scale | Standard Deviation 0 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Study Eye | -0.183 Score on scale | Standard Deviation 0.4072 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Non-Study Eye | -0.100 Score on scale | Standard Deviation 0.05 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Study Eye | 1.267 Score on scale | Standard Deviation 0.0289 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Non-Study Eye | -0.100 Score on scale | Standard Deviation 0.1323 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Non-Study Eye | -0.050 Score on scale | Standard Deviation 0.1323 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Study Eye | -0.217 Score on scale | Standard Deviation 0.5346 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Study Eye | -0.033 Score on scale | Standard Deviation 0.4163 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Non-Study | 1.350 Score on scale | Standard Deviation 0.1803 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Non-Study Eye | 0.000 Score on scale | Standard Deviation 0.05 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Non-Study Eye | 0.050 Score on scale | Standard Deviation 0.05 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Non-Study | 1.100 Score on scale | Standard Deviation 0.3279 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Study Eye | -0.167 Score on scale | Standard Deviation 0.3014 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 6: Study Eye | 0.117 Score on scale | Standard Deviation 0.2021 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Study Eye | -0.017 Score on scale | Standard Deviation 0.3329 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 3: Non-Study Eye | 0.000 Score on scale | Standard Deviation 0.1 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 12: Non-Study Eye | -0.050 Score on scale | Standard Deviation 0.1323 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Baseline: Study Eye | 1.067 Score on scale | Standard Deviation 0.611 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Contrast Sensitivity (CS) Score | Change From Baseline at Month 24: Study Eye | -0.117 Score on scale | Standard Deviation 0.2466 |
Secondary
Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence
Fundus Autofluoroscence was used to assess the distance from FC to nearest border of preserved autofluoroscence. A negative change from baseline indicates a decline in the total area of preserved autofluoroscence.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Non-Study Eye | -255.50 mm^2 | Standard Deviation 297.692 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 18: Non-Study Eye | -358.00 mm^2 | Standard Deviation 318.198 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Non-Study Eye | -276.50 mm^2 | Standard Deviation 324.562 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Non-Study Eye | 2609.00 mm^2 | Standard Deviation 386.08 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 18: Study Eye | -1493.00 mm^2 | Standard Deviation 1829.992 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Study Eye | -87.00 mm^2 | Standard Deviation 24.042 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 12: Study Eye | -1489.50 mm^2 | Standard Deviation 1829.285 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Study Eye | 2394.50 mm^2 | Standard Deviation 665.387 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 9: Non-Study Eye | -310.50 mm^2 | Standard Deviation 333.047 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 24: Study Eye | -1501.00 mm^2 | Standard Deviation 1820.093 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 12: Non-Study Eye | -353.50 mm^2 | Standard Deviation 318.905 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 9: Study Eye | -140.00 mm^2 | Standard Deviation 41.012 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 6: Non-Study Eye | -297.00 mm^2 | Standard Deviation 349.311 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 6: Study Eye | -128.50 mm^2 | Standard Deviation 54.447 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 24: Non-Study Eye | -391.00 mm^2 | Standard Deviation 301.227 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Study Eye | -33.00 mm^2 | Standard Deviation 5.657 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 18: Study Eye | -55.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 18: Non-Study Eye | -86.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 24: Study Eye | -69.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 24: Non-Study Eye | -91.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Non-Study Eye | -19.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Study Eye | -39.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Study Eye | -16.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Non-Study Eye | -30.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Non-Study Eye | -24.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 6: Study Eye | -24.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 6: Non-Study Eye | -41.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 9: Study Eye | -35.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 9: Non-Study Eye | -58.00 mm^2 | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Study Eye | -14.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 24: Non-Study Eye | -2646.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Study Eye | 3018.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 12: Non-Study Eye | -422.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 18: Study Eye | -310.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 9: Non-Study Eye | -413.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 6: Non-Study Eye | -462.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 6: Study Eye | -179.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 18: Non-Study Eye | -425.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Study Eye | -52.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 12: Study Eye | -282.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Study Eye | -138.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 24: Study Eye | -226.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Non-Study Eye | 3052.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Non-Study Eye | -281.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 9: Study Eye | -281.00 mm^2 | — |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Non-Study Eye | -375.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 9: Study Eye | -94.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Study Eye | 361.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 18: Study Eye | -123.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 6: Study Eye | -93.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 24: Study Eye | -125.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 6: Non-Study Eye | -36.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Non-Study Eye | 369.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 12: Non-Study Eye | -39.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Non-Study Eye | -22.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Study Eye | -14.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 9: Non-Study Eye | -38.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 18: Non-Study Eye | -11.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 24: Non-Study Eye | -13.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Study Eye | -89.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Non-Study Eye | -18.00 mm^2 | — |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 12: Study Eye | -101.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 24: Non-Study Eye | 62.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Study Eye | 2853.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Non-Study Eye | 2816.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Study Eye | -5.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Non-Study Eye | -12.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Study Eye | -104.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Non-Study Eye | -93.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 6: Study Eye | -122.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 6: Non-Study Eye | -102.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 9: Study Eye | -140.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 9: Non-Study Eye | 92.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 12: Study Eye | -708.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 12: Non-Study Eye | 89.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 18: Study Eye | -1278.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 18: Non-Study Eye | 65.00 mm^2 | — |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 24: Study Eye | -1293.00 mm^2 | — |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 3: Non-Study Eye | -21.00 mm^2 | — |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Change From Baseline at Month 1: Non-Study Eye | -3.00 mm^2 | — |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Distance From Foveal Center (FC) to Nearest Border of Preserved Autofluoroscence | Baseline: Non-Study Eye | 4047.00 mm^2 | — |
Secondary
Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence
Fundus Autofluoroscence was used to assess the total area of preserved autofluoroscence. Areas of preserved AF were identified as well-demarcated regions of relative hyper autofluorescence (hyper AF) compared with the background areas of surrounding atrophy. A negative change from baseline indicates a decline in total area of preserved autofluoroscence.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Baseline: Study Eye | 27.050 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Baseline: Non-Study Eye | 22.910 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 9: Non-Study Eye | -3.100 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 12: Study Eye | -3.640 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 12: Non-Study Eye | -3.760 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 18: Study Eye | -3.670 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 18: Non-Study Eye | -3.830 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 24: Study Eye | -3.740 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 24: Non-Study Eye | -4.120 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 1: Study Eye | -1.820 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 1: Non-Study Eye | -2.420 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 3: Study Eye | -2.940 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 3: Non-Study Eye | -2.650 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 6: Study Eye | -3.460 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 6: Non-Study Eye | -3.050 mm^2 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 9: Study Eye | -3.470 mm^2 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Baseline: Non-Study Eye | 50.640 mm^2 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 18: Non-Study Eye | -11.700 mm^2 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 9: Non-Study Eye | -9.130 mm^2 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 1: Non-Study Eye | -8.620 mm^2 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 6: Non-Study Eye | -6.530 mm^2 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 12: Non-Study Eye | -9.220 mm^2 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Fundus Autofluoroscence- Mean Total Area of Preserved Autofluoroscence | Change From Baseline at Month 3: Non-Study Eye | -5.150 mm^2 |
Secondary
Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. BCVA was reported as number of letters read correctly by the participants using the ETDRS Scale (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Here negative values indicate decline in BCVA.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Study Eye | 6.33 letters | Standard Deviation 2.309 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Non-Study Eye | 60.67 letters | Standard Deviation 2.082 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Study Eye | 3.67 letters | Standard Deviation 3.055 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 3.00 letters | Standard Deviation 3 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Study Eye | 27.67 letters | Standard Deviation 8.145 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 3.00 letters | Standard Deviation 1 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Study Eye | 5.00 letters | Standard Deviation 1 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | -1.00 letters | Standard Deviation 7.211 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Study Eye | 1.33 letters | Standard Deviation 4.619 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | -5.00 letters | Standard Deviation 5.292 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Study Eye | 4.67 letters | Standard Deviation 4.509 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | -1.67 letters | Standard Deviation 2.309 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Study Eye | 3.00 letters | Standard Deviation 8.718 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Non-Study Eye | -4.00 letters | Standard Deviation 6.245 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Study Eye | -2.00 letters | Standard Deviation 15.588 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Non-Study Eye | -3.67 letters | Standard Deviation 5.508 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 1.00 letters | Standard Deviation 4.359 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Study Eye | -0.67 letters | Standard Deviation 0.577 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | -0.67 letters | Standard Deviation 4.726 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Study Eye | -3.67 letters | Standard Deviation 3.786 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Study Eye | 0.33 letters | Standard Deviation 2.517 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Study Eye | 49.67 letters | Standard Deviation 9.452 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Non-Study Eye | 0.00 letters | Standard Deviation 5 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Study Eye | -2.00 letters | Standard Deviation 3.606 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | -0.33 letters | Standard Deviation 3.215 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Study Eye | 0.00 letters | Standard Deviation 3.606 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Non-Study Eye | 57.33 letters | Standard Deviation 5.686 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Non-Study Eye | 0.67 letters | Standard Deviation 0.577 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Study Eye | -2.00 letters | Standard Deviation 3.464 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | -0.67 letters | Standard Deviation 5.033 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Study Eye | -2.00 letters | Standard Deviation 5.292 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 1.67 letters | Standard Deviation 1.528 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Study Eye | -3.33 letters | Standard Deviation 3.215 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 1.00 letters | Standard Deviation 1 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Study Eye | 0.67 letters | Standard Deviation 2.082 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | -1.67 letters | Standard Deviation 1.528 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Study Eye | 0.33 letters | Standard Deviation 0.577 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | -0.33 letters | Standard Deviation 3.215 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Study Eye | 1.33 letters | Standard Deviation 4.509 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 1.00 letters | Standard Deviation 1 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Study Eye | 0.67 letters | Standard Deviation 5.132 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | -0.33 letters | Standard Deviation 0.577 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Non-Study Eye | -2.33 letters | Standard Deviation 1.528 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Study Eye | -3.33 letters | Standard Deviation 5.132 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Non-Study Eye | -0.33 letters | Standard Deviation 2.517 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Study Eye | 64.33 letters | Standard Deviation 7.095 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Non-Study Eye | 66.33 letters | Standard Deviation 2.517 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Study Eye | -1.00 letters | Standard Deviation 1.732 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 0.33 letters | Standard Deviation 0.577 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Study Eye | 4.00 letters | Standard Deviation 5.292 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Study Eye | 1.67 letters | Standard Deviation 4.726 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Study Eye | -1.33 letters | Standard Deviation 6.506 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Non-Study Eye | 62.67 letters | Standard Deviation 22.279 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | 2.00 letters | Standard Deviation 4.359 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Study Eye | 5.00 letters | Standard Deviation 7 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Non-Study Eye | 1.33 letters | Standard Deviation 2.517 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Study Eye | 4.33 letters | Standard Deviation 4.933 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 3.00 letters | Standard Deviation 3.606 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | 3.67 letters | Standard Deviation 3.055 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Study Eye | 3.33 letters | Standard Deviation 3.786 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Study Eye | 63.67 letters | Standard Deviation 20.551 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 2.33 letters | Standard Deviation 2.309 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Non-Study Eye | 2.33 letters | Standard Deviation 4.509 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Study Eye | 3.67 letters | Standard Deviation 5.686 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 2.00 letters | Standard Deviation 4.583 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Study Eye | -0.67 letters | Standard Deviation 4.041 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Study Eye | 0.33 letters | Standard Deviation 6.028 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Study Eye | 70.67 letters | Standard Deviation 4.163 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Study Eye | -3.67 letters | Standard Deviation 8.737 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 4.67 letters | Standard Deviation 4.509 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | 4.00 letters | Standard Deviation 4.359 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Study Eye | -13.33 letters | Standard Deviation 32.747 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Study Eye | -15.00 letters | Standard Deviation 40.286 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Non-Study Eye | 2.00 letters | Standard Deviation 7.81 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | 6.67 letters | Standard Deviation 6.429 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Study Eye | -3.67 letters | Standard Deviation 16.073 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Non-Study Eye | 73.33 letters | Standard Deviation 4.163 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 5.67 letters | Standard Deviation 8.622 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Study Eye | -9.33 letters | Standard Deviation 28.919 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Non-Study Eye | 5.00 letters | Standard Deviation 7.81 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | -0.67 letters | Standard Deviation 1.528 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Study Eye | -2.33 letters | Standard Deviation 9.074 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Study Eye | -5.67 letters | Standard Deviation 6.11 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Study Eye | 0.67 letters | Standard Deviation 6.506 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Non-Study Eye | -0.33 letters | Standard Deviation 5.508 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 2.00 letters | Standard Deviation 4.359 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 24: Non-Study Eye | -2.00 letters | Standard Deviation 3 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Study Eye | -2.33 letters | Standard Deviation 8.327 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | 1.00 letters | Standard Deviation 2 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | -2.67 letters | Standard Deviation 1.155 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Non-Study Eye | 75.00 letters | Standard Deviation 4.583 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 18: Study Eye | -5.00 letters | Standard Deviation 8.544 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 1: Study Eye | -0.67 letters | Standard Deviation 10.693 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | -0.33 letters | Standard Deviation 0.577 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Change From Baseline at Month 6: Study Eye | -0.67 letters | Standard Deviation 5.033 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Best Corrected Visual Acuity (BCVA) Reported as Letters | Baseline: Study Eye | 67.33 letters | Standard Deviation 15.044 |
Secondary
Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. LLVA was reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Here negative values indicate decline in LLVA.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 3: Study Eye | 14.00 letters | Standard Deviation 11.314 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Baseline: Non-Study Eye | 37.50 letters | Standard Deviation 24.749 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 1: Study Eye | 10.00 letters | Standard Deviation 9.899 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 10.00 letters | Standard Deviation 18.385 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Baseline: Study Eye | 41.00 letters | Standard Deviation 18.385 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 10.00 letters | Standard Deviation 16.971 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 6: Study Eye | 11.50 letters | Standard Deviation 7.778 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | 8.00 letters | Standard Deviation 15.556 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 9: Study Eye | 0.50 letters | Standard Deviation 4.95 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 0.50 letters | Standard Deviation 4.95 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 12: Study Eye | 3.50 letters | Standard Deviation 0.707 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | 7.00 letters | Standard Deviation 9.899 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 18: Study Eye | 6.50 letters | Standard Deviation 7.778 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 18: Non-Study Eye | 9.00 letters | Standard Deviation 21.213 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 24: Study Eye | 3.00 letters | Standard Deviation 8.485 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 24: Non-Study Eye | 5.50 letters | Standard Deviation 24.749 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 1.00 letters | Standard Deviation 1 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 9: Study Eye | 10.00 letters | Standard Deviation 6.557 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 24: Non-Study Eye | 0.67 letters | Standard Deviation 4.041 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | 6.67 letters | Standard Deviation 8.327 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 24: Study Eye | 9.33 letters | Standard Deviation 14.295 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 2.00 letters | Standard Deviation 4.359 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 1: Study Eye | 0.33 letters | Standard Deviation 0.577 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 12: Study Eye | 16.00 letters | Standard Deviation 13.454 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 3: Study Eye | 7.33 letters | Standard Deviation 6.658 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 6: Study Eye | 8.33 letters | Standard Deviation 7.234 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | -0.33 letters | Standard Deviation 7.506 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Baseline: Non-Study Eye | 37.67 letters | Standard Deviation 32.808 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 18: Study Eye | 10.67 letters | Standard Deviation 8.622 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | 1.67 letters | Standard Deviation 2.887 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 18: Non-Study Eye | 2.33 letters | Standard Deviation 2.517 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Baseline: Study Eye | 34.33 letters | Standard Deviation 29.939 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 3.00 letters | Standard Deviation 4.583 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 3: Study Eye | -14.33 letters | Standard Deviation 38.214 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 18: Non-Study Eye | 5.67 letters | Standard Deviation 4.726 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 6: Study Eye | -16.67 letters | Standard Deviation 35.81 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | 5.33 letters | Standard Deviation 1.155 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 24: Non-Study Eye | 3.33 letters | Standard Deviation 3.512 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 9: Study Eye | -14.33 letters | Standard Deviation 37.82 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 2.00 letters | Standard Deviation 3.464 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 24: Study Eye | -14.67 letters | Standard Deviation 38.371 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 12: Study Eye | -11.33 letters | Standard Deviation 40.612 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | 9.00 letters | Standard Deviation 4.359 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Baseline: Study Eye | 58.00 letters | Standard Deviation 3 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Baseline: Non-Study Eye | 61.00 letters | Standard Deviation 2.646 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 18: Study Eye | -12.33 letters | Standard Deviation 40.079 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 1: Study Eye | 3.00 letters | Standard Deviation 5.292 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 3.00 letters | Standard Deviation 5.196 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 24: Non-Study Eye | -12.67 letters | Standard Deviation 11.547 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | 0.67 letters | Standard Deviation 3.215 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 1: Study Eye | 4.67 letters | Standard Deviation 26.502 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Baseline: Study Eye | 41.67 letters | Standard Deviation 34.646 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 18: Non-Study Eye | -4.33 letters | Standard Deviation 7.234 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 6: Study Eye | 7.33 letters | Standard Deviation 9.713 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 18: Study Eye | 8.33 letters | Standard Deviation 5.508 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Baseline: Non-Study Eye | 57.33 letters | Standard Deviation 14.844 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 3: Study Eye | -7.67 letters | Standard Deviation 10.263 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 3.33 letters | Standard Deviation 2.309 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 2.00 letters | Standard Deviation 3.464 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 12: Study Eye | 8.33 letters | Standard Deviation 11.59 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 24: Study Eye | -1.67 letters | Standard Deviation 6.506 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 9: Study Eye | 4.33 letters | Standard Deviation 8.083 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | -4.33 letters | Standard Deviation 7.572 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Low Luminance Visual Acuity (LLVA) Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | 4.00 letters | Standard Deviation 6.083 |
Secondary
Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry
MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' is assigned a value of '-1' by MAIA in the calculation. Improvement in mean sensitivity in center grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points out of the 16 central points. Here negative values indicate a decline in retinal sensitivity.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure. 'Number of participants analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -0.10 dBs | Standard Deviation 0.355 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.17 dBs | Standard Deviation 0.344 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | 0.21 dBs | Standard Deviation 0.473 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | -0.33 dBs | Standard Deviation 0.577 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 0.52 dBs | Standard Deviation 0.477 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 0.40 dBs | Standard Deviation 0.407 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 0.54 dBs | Standard Deviation 0.485 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 0.21 dBs | Standard Deviation 0.219 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | 0.42 dBs | Standard Deviation 1.122 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | -0.46 dBs | Standard Deviation 0.469 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.06 dBs | Standard Deviation 0.534 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | -0.35 dBs | Standard Deviation 0.509 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 0.23 dBs | Standard Deviation 1.358 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 0.19 dBs | Standard Deviation 0.272 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 0.33 dBs | Standard Deviation 1.748 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | 0.04 dBs | Standard Deviation 0.253 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 3.31 dBs | Standard Deviation 2.563 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -1.09 dBs | Standard Deviation 1.37 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.91 dBs | Standard Deviation 0.575 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.34 dBs | Standard Deviation 2.607 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | -1.09 dBs | Standard Deviation 1.282 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 0.47 dBs | Standard Deviation 1.282 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | -0.06 dBs | Standard Deviation 0.265 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | -1.13 dBs | Standard Deviation 0.177 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | -1.63 dBs | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | -1.88 dBs | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 0.13 dBs | Standard Deviation 1.945 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | 0.19 dBs | Standard Deviation 2.21 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | -0.09 dBs | Standard Deviation 0.928 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.81 dBs | Standard Deviation 1.768 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 1.78 dBs | Standard Deviation 1.282 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 0.09 dBs | Standard Deviation 1.282 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.98 dBs | Standard Deviation 1.531 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 3.35 dBs | Standard Deviation 0.911 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 6.92 dBs | Standard Deviation 2.221 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 6.10 dBs | Standard Deviation 0.844 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 4.65 dBs | Standard Deviation 3.851 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | 0.20 dBs | Standard Deviation 2.751 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 5.10 dBs | Standard Deviation 1.89 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 4.10 dBs | Standard Deviation 2.908 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 5.63 dBs | Standard Deviation 2.394 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -1.02 dBs | Standard Deviation 0.581 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | 2.69 dBs | Standard Deviation 2.507 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -1.15 dBs | Standard Deviation 2.094 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | 0.02 dBs | Standard Deviation 0.94 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | 2.75 dBs | Standard Deviation 2.683 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | -0.33 dBs | Standard Deviation 1.347 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -1.19 dBs | Standard Deviation 1.535 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | 0.42 dBs | Standard Deviation 1.951 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.19 dBs | Standard Deviation 0.272 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 3.25 dBs | Standard Deviation 8.199 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 3.98 dBs | Standard Deviation 5.09 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 8.21 dBs | Standard Deviation 5.57 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | 1.48 dBs | Standard Deviation 5.236 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 1.73 dBs | Standard Deviation 8.714 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | -0.06 dBs | Standard Deviation 1.789 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 3.69 dBs | Standard Deviation 6.308 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 1.19 dBs | Standard Deviation 6.094 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | 2.10 dBs | Standard Deviation 3.437 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | -0.56 dBs | Standard Deviation 1.207 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | 2.92 dBs | Standard Deviation 5.55 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | 0.33 dBs | Standard Deviation 1.134 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 6.52 dBs | Standard Deviation 3.398 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | -0.67 dBs | Standard Deviation 0.806 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | 0.71 dBs | Standard Deviation 3.263 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | -2.38 dBs | Standard Deviation 5.177 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | 2.19 dBs | Standard Deviation 0.933 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | -2.50 dBs | Standard Deviation 5.314 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | 2.52 dBs | Standard Deviation 1.714 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 2.25 dBs | Standard Deviation 2.121 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | 2.31 dBs | Standard Deviation 2.99 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | -2.79 dBs | Standard Deviation 6.733 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | 1.92 dBs | Standard Deviation 3.085 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | -4.90 dBs | Standard Deviation 5.25 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | 2.06 dBs | Standard Deviation 1.137 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | 1.40 dBs | Standard Deviation 2.69 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 13.46 dBs | Standard Deviation 6.316 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 13.71 dBs | Standard Deviation 8.447 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | -0.63 dBs | Standard Deviation 4.154 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | -3.58 dBs | Standard Deviation 7.476 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | -1.90 dBs | Standard Deviation 7.686 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 7.75 dBs | Standard Deviation 7.742 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | -2.19 dBs | Standard Deviation 2.189 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | -1.88 dBs | Standard Deviation 5.862 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | -0.59 dBs | Standard Deviation 2.607 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | 0.19 dBs | Standard Deviation 2.063 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | -1.09 dBs | Standard Deviation 5.436 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -0.29 dBs | Standard Deviation 1.835 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 0.56 dBs | Standard Deviation 5.59 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | 0.40 dBs | Standard Deviation 2.032 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.42 dBs | Standard Deviation 0.289 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | -3.35 dBs | Standard Deviation 2.894 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 0.77 dBs | Standard Deviation 7.096 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.65 dBs | Standard Deviation 1.156 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 7.54 dBs | Standard Deviation 7.542 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 0.85 dBs | Standard Deviation 5.105 |
Secondary
Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry
MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' is assigned a value of '-1' by MAIA in the calculation. Improvement in mean sensitivity in whole grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points of the grid as a whole (68 points). Here negative values indicate a decline in retinal sensitivity.
Time frame: Baseline, Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure. 'Number of participants analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 0.14 dBs | Standard Deviation 0.137 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | -0.38 dBs | Standard Deviation 0.54 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 0.12 dBs | Standard Deviation 0.309 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | 0.18 dBs | Standard Deviation 0.481 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | -0.19 dBs | Standard Deviation 0.69 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.06 dBs | Standard Deviation 0.292 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 0.04 dBs | Standard Deviation 0.334 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.24 dBs | Standard Deviation 0.331 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | -0.18 dBs | Standard Deviation 0.145 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | -0.37 dBs | Standard Deviation 0.467 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | -0.16 dBs | Standard Deviation 0.165 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -0.30 dBs | Standard Deviation 0.417 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | -0.23 dBs | Standard Deviation 0.213 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | -0.33 dBs | Standard Deviation 0.412 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | -0.40 dBs | Standard Deviation 0.382 |
| Part 1: BIIB112 Dose 1 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | -0.37 dBs | Standard Deviation 0.427 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.76 dBs | Standard Deviation 1.165 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 0.31 dBs | Standard Deviation 1.456 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.32 dBs | Standard Deviation 1.872 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 0.19 dBs | Standard Deviation 0.957 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 0.24 dBs | Standard Deviation 1.185 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 0.20 dBs | Standard Deviation 0.281 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | -0.57 dBs | Standard Deviation 1.435 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | -0.50 dBs | Standard Deviation 0.458 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -0.46 dBs | Standard Deviation 1.633 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 0.74 dBs | Standard Deviation 1.82 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 1.47 dBs | Standard Deviation 1.061 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | -1.44 dBs | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 0.30 dBs | Standard Deviation 1.612 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | -0.12 dBs | Standard Deviation 1.83 |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | -0.96 dBs | — |
| Part 1: BIIB112 Dose 2 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.29 dBs | Standard Deviation 1.549 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | 1.17 dBs | Standard Deviation 1.19 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.08 dBs | Standard Deviation 0.938 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 2.44 dBs | Standard Deviation 1.564 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.29 dBs | Standard Deviation 1.351 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 2.28 dBs | Standard Deviation 1.534 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.51 dBs | Standard Deviation 0.773 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 2.02 dBs | Standard Deviation 2.177 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | 1.66 dBs | Standard Deviation 1.79 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 1.72 dBs | Standard Deviation 1.892 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -0.24 dBs | Standard Deviation 0.153 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | 0.14 dBs | Standard Deviation 0.221 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | 1.16 dBs | Standard Deviation 1.144 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | 0.07 dBs | Standard Deviation 0.509 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 0.21 dBs | Standard Deviation 0.435 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 1.50 dBs | Standard Deviation 1.419 |
| Part 1: BIIB112 Dose 3 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 2.42 dBs | Standard Deviation 0.283 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.11 dBs | Standard Deviation 0.111 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 0.90 dBs | Standard Deviation 4.233 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 0.58 dBs | Standard Deviation 5.061 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 0.08 dBs | Standard Deviation 2.436 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 2.30 dBs | Standard Deviation 1.559 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | 0.76 dBs | Standard Deviation 1.345 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | 0.98 dBs | Standard Deviation 3.51 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | 0.18 dBs | Standard Deviation 0.191 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 1.28 dBs | Standard Deviation 3.541 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | 0.77 dBs | Standard Deviation 1.405 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | 3.86 dBs | Standard Deviation 5.648 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | 1.37 dBs | Standard Deviation 4.233 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 2.22 dBs | Standard Deviation 1.536 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | 0.68 dBs | Standard Deviation 1.223 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | 0.24 dBs | Standard Deviation 0.153 |
| Part 1: BIIB112 Dose 4 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 0.90 dBs | Standard Deviation 5.011 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | 1.24 dBs | Standard Deviation 1.639 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 0.56 dBs | Standard Deviation 3.243 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | -1.87 dBs | Standard Deviation 4.073 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 8.87 dBs | Standard Deviation 10.784 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | -0.60 dBs | Standard Deviation 1.596 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | 1.38 dBs | Standard Deviation 1.005 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | 1.76 dBs | Standard Deviation 0.47 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | -2.37 dBs | Standard Deviation 1.225 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | -0.22 dBs | Standard Deviation 2.6 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | 0.75 dBs | Standard Deviation 1.427 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | 1.72 dBs | Standard Deviation 1.144 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | -0.87 dBs | Standard Deviation 2.229 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 9.11 dBs | Standard Deviation 12.466 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | 2.05 dBs | Standard Deviation 0.816 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | -0.72 dBs | Standard Deviation 1.253 |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | 1.24 dBs | Standard Deviation 1.265 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.84 dBs | Standard Deviation 1.101 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | -0.13 dBs | Standard Deviation 4.044 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Study Eye | -2.26 dBs | Standard Deviation 6.009 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | -0.60 dBs | Standard Deviation 1.383 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Non-Study Eye | -1.19 dBs | Standard Deviation 2.267 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | -0.41 dBs | Standard Deviation 1.157 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 24: Non-Study Eye | -1.73 dBs | Standard Deviation 2.481 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | -0.41 dBs | Standard Deviation 4.208 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -0.82 dBs | Standard Deviation 1.248 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.66 dBs | Standard Deviation 1.474 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 5.35 dBs | Standard Deviation 8.579 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 18: Study Eye | -1.32 dBs | Standard Deviation 4.721 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | -1.69 dBs | Standard Deviation 4.341 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.65 dBs | Standard Deviation 0.407 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 0.51 dBs | Standard Deviation 2.154 |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points Assessed by MAIA Microperimetry | Baseline: Study Eye | 4.26 dBs | Standard Deviation 6.732 |
Secondary
Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision
Visual field testing was performed to assess the volume of 30-degree hill vision, reported as dBs. Reliability Factor (RF)=number of false positive responses + number of false negative responses/number of false positive presentations + number of false negative presentations\*100. If there are 0 responses, then RF value=0. RFpositive=number of false positive responses/number of false positive presentations\*100. If RF≤ 20% measurement is considered reliable. If 20% \< RF ≤ 25% and RFpositive ≤ 10% measurement is also considered reliable. Otherwise if 20% \< RF ≤ 25% and RFpositive \> 10%, or RF \> 25%, measurement is not reliable. Only reliable measurements were included for analysis of this outcome measure. Here negative values indicate decline in volume of 30-degree hill vision.
Time frame: Baseline, Months 6, 12, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Baseline: Study Eye | 2.73 dBs |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Change From Baseline at Month 12: Study Eye | 0.33 dBs |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Change From Baseline at Month 24: Study Eye | -1.89 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Change From Baseline at Month 6: Study Eye | -2.14 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Change From Baseline at Month 6: Non-Study Eye | -1.10 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Change From Baseline at Month 24: Study Eye | -3.08 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Change From Baseline at Month 12: Study Eye | -2.80 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Change From Baseline at Month 12: Non-Study Eye | -1.02 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Change From Baseline at Month 24: Non-Study Eye | -2.11 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Baseline: Study Eye | 5.07 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of 30-Degree Hill of Vision | Baseline: Non-Study Eye | 5.17 dBs |
Secondary
Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision
Visual field testing was performed to assess the volume of full field of hill vision, reported as dBs. RF =number of false positive responses + number of false negative responses/number of false positive presentations + number of false negative presentations\*100. If there are 0 responses, then RF value=0. RFpositive=number of false positive responses/number of false positive presentations\*100. If RF≤ 20% measurement is considered reliable. If 20% \< RF ≤ 25% and RFpositive ≤ 10% measurement is also considered reliable. Otherwise if 20% \< RF ≤ 25% and RFpositive \> 10%, or RF \> 25%, measurement is not reliable. Only reliable measurements were included for analysis of this outcome measure. Here negative values indicate decline in volume of 30-degree hill vision.
Time frame: Baseline, Months 6, 12, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Baseline: Study Eye | 15.77 dBs |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Change From Baseline at Month 12: Study Eye | 1.29 dBs |
| Part 1: BIIB112 Dose 5 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Change From Baseline at Month 24: Study Eye | -6.28 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Change From Baseline at Month 6: Study Eye | -0.86 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Change From Baseline at Month 6: Non-Study Eye | -4.91 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Change From Baseline at Month 24: Study Eye | -5.36 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Change From Baseline at Month 12: Study Eye | -2.98 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Change From Baseline at Month 12: Non-Study Eye | -3.70 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Change From Baseline at Month 24: Non-Study Eye | -7.87 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Baseline: Study Eye | 18.31 dBs |
| Part 1: BIIB112 Dose 6 | Part 1: Change From Baseline in Mean Volume of Full Field Hill of Vision | Baseline: Non-Study Eye | 23.41 dBs |
Secondary
Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters increase from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters increase from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters loss from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters loss from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters increase from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters increase from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters loss from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters loss from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters increase from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.03 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters increase from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 18: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 6: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 1: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters loss from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 18: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 24: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 33.3 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters loss from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.00 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 18: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 24: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 18: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Percentage of eyes with a change from baseline of ≥ -5 letters for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 24: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 6: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 18: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 1: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for BCVA | Month 3: Study Eye | 66.7 percentage of eyes |
Secondary
Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Percentage of eyes with a change from baseline of ≥ -5 letters for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 12: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 6: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 24: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 9: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 6: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 18: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 1: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 3: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 24: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 18: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 1: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 18: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 1: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 1: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 3: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 6: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 6: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 9: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 12: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 18: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 24: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 24: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 18: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 24: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 1: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 18: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 1: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 6: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 3: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 6: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 24: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 9: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 9: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 24: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 1: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 18: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 24: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 18: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 6: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 1: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 6: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Eyes With Change From Baseline > -5 Letters for LLVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
Secondary
Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry
MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Improvement in Retinal Sensitivity in center grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points out of the 16 central points.
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure. 'Number of participants analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 100.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 50.0 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 33.3 percentage of study eyes |
Secondary
Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry
MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Improvement in Retinal Sensitivity in whole grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points of the grid as a whole (68 points).
Time frame: Months 1, 3, 6, 9, 12, 18, and 24
Population: Safety analysis set included all participants who received study treatment (vitrectomy/BIIB112). 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure. 'Number of participants analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 50.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 0.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 50.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 100.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 100.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 4 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 5 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 50.0 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 24 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 100.0 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 66.7 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 18 | 50.0 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 6 | Part 1: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 66.7 percentage of study eyes |
Secondary
Part 2: Change From Baseline in BCVA Reported as Letters
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. BCVA was reported as number of letters read correctly by the participant, using the ETDRS Scale (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Here negative values indicate a decline in BCVA.
Time frame: Baseline, Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants who were randomized, under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Baseline: Non-Study Eye | 72.89 letters | Standard Deviation 6.846 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | -1.56 letters | Standard Deviation 2.833 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 2: Non-Study Eye | -0.11 letters | Standard Deviation 1.269 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Baseline: Study Eye | 68.78 letters | Standard Deviation 5.954 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 6: Study Eye | 1.00 letters | Standard Deviation 2 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 3: Study Eye | 1.38 letters | Standard Deviation 2.615 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 12: Study Eye | 0.22 letters | Standard Deviation 2.949 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 0.13 letters | Standard Deviation 2.642 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 1: Study Eye | 0.44 letters | Standard Deviation 2.833 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | -4.11 letters | Standard Deviation 3.983 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | -1.78 letters | Standard Deviation 2.949 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | -0.89 letters | Standard Deviation 2.028 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 9: Study Eye | 0.44 letters | Standard Deviation 1.944 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 2: Study Eye | 0.22 letters | Standard Deviation 2.108 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 12: Study Eye | -4.00 letters | Standard Deviation 17.436 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 0.00 letters | Standard Deviation 4.11 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Baseline: Study Eye | 65.90 letters | Standard Deviation 10.104 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Baseline: Non-Study Eye | 68.50 letters | Standard Deviation 9.675 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 1: Study Eye | 1.60 letters | Standard Deviation 6.45 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 2: Study Eye | -1.00 letters | Standard Deviation 12.392 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 2: Non-Study Eye | 0.60 letters | Standard Deviation 2.836 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 3: Study Eye | 0.10 letters | Standard Deviation 6.54 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 1.10 letters | Standard Deviation 2.47 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 6: Study Eye | 2.44 letters | Standard Deviation 5.003 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | 0.67 letters | Standard Deviation 1.581 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 9: Study Eye | -2.50 letters | Standard Deviation 14.263 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 1.00 letters | Standard Deviation 2 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | 0.89 letters | Standard Deviation 3.1 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 2: Study Eye | 0.00 letters | Standard Deviation 8.957 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 12: Study Eye | -0.75 letters | Standard Deviation 3.37 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | 1.00 letters | Standard Deviation 4.629 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 3.80 letters | Standard Deviation 3.36 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Baseline: Study Eye | 68.20 letters | Standard Deviation 8.991 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 9: Study Eye | -0.57 letters | Standard Deviation 1.397 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 1: Study Eye | 0.60 letters | Standard Deviation 7.545 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | 2.14 letters | Standard Deviation 3.976 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 3: Study Eye | -0.30 letters | Standard Deviation 11.036 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 1.71 letters | Standard Deviation 3.147 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 3.20 letters | Standard Deviation 2.86 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 2: Non-Study Eye | 3.10 letters | Standard Deviation 2.644 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Baseline: Non-Study Eye | 68.80 letters | Standard Deviation 6.989 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in BCVA Reported as Letters | Change From Baseline at Month 6: Study Eye | -0.38 letters | Standard Deviation 5.63 |
Secondary
Part 2: Change From Baseline in Mean LLVA Reported as Letters
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. LLVA was reported as number of letters read correctly by the participant, using the ETDRS Scale (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Here negative values indicate a decline in LLVA.
Time frame: Baseline, Months 1, 3, 6, 9, and 12
Population: ITT analysis set included all participants who were randomized, under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Baseline: Study Eye | 50.22 letters | Standard Deviation 13.349 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Baseline: Non-Study Eye | 54.78 letters | Standard Deviation 11.872 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 1: Study Eye | 0.56 letters | Standard Deviation 7.618 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 0.22 letters | Standard Deviation 5.215 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 3: Study Eye | 3.63 letters | Standard Deviation 7.23 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | -0.63 letters | Standard Deviation 8.158 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 6: Study Eye | 1.22 letters | Standard Deviation 7.032 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | 0.11 letters | Standard Deviation 6.274 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 9: Study Eye | -1.78 letters | Standard Deviation 7.225 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | -3.11 letters | Standard Deviation 7.491 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 12: Study Eye | -2.22 letters | Standard Deviation 7.412 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | -4.44 letters | Standard Deviation 7.002 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | -3.56 letters | Standard Deviation 11.652 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Baseline: Study Eye | 39.30 letters | Standard Deviation 22.246 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 6: Study Eye | 8.00 letters | Standard Deviation 18.581 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 9: Study Eye | 8.38 letters | Standard Deviation 16.088 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Baseline: Non-Study Eye | 49.50 letters | Standard Deviation 19.127 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 0.50 letters | Standard Deviation 3.749 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 12: Study Eye | 5.11 letters | Standard Deviation 14.426 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 1: Study Eye | 11.30 letters | Standard Deviation 16.918 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | -3.56 letters | Standard Deviation 8.472 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 3: Study Eye | 8.10 letters | Standard Deviation 16.251 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | -3.00 letters | Standard Deviation 9.165 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | -1.13 letters | Standard Deviation 6.749 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 1: Non-Study Eye | 3.50 letters | Standard Deviation 4.882 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 3: Study Eye | -3.50 letters | Standard Deviation 22.609 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 9: Non-Study Eye | 4.00 letters | Standard Deviation 4.082 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 3: Non-Study Eye | 1.20 letters | Standard Deviation 3.553 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 6: Study Eye | 3.25 letters | Standard Deviation 14.636 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 6: Non-Study Eye | 2.13 letters | Standard Deviation 2.85 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 12: Study Eye | -0.63 letters | Standard Deviation 11.575 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Baseline: Study Eye | 47.90 letters | Standard Deviation 14.97 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Baseline: Non-Study Eye | 51.60 letters | Standard Deviation 9.524 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 9: Study Eye | 6.00 letters | Standard Deviation 12.356 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 1: Study Eye | -1.30 letters | Standard Deviation 18.397 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean LLVA Reported as Letters | Change From Baseline at Month 12: Non-Study Eye | -1.50 letters | Standard Deviation 4.309 |
Secondary
Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry
MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Mean Sensitivity in center grid was defined as the mean in dB of the 16 points located in the center of the grid. Here negative values indicate a decline in retinal sensitivity.
Time frame: Baseline, Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants who were randomized, under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 0.65 dBs | Standard Deviation 3.272 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Non-Study Eye | -0.34 dBs | Standard Deviation 2.027 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 1.53 dBs | Standard Deviation 3.086 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.69 dBs | Standard Deviation 2.199 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 1.17 dBs | Standard Deviation 2.76 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 9.56 dBs | Standard Deviation 3.321 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 0.72 dBs | Standard Deviation 3.208 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -1.24 dBs | Standard Deviation 1.253 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | -1.01 dBs | Standard Deviation 1.943 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.26 dBs | Standard Deviation 1.692 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -2.23 dBs | Standard Deviation 4.018 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Study Eye | 6.78 dBs | Standard Deviation 3.488 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Study Eye | 1.62 dBs | Standard Deviation 2.846 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | -0.11 dBs | Standard Deviation 4.446 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 2.52 dBs | Standard Deviation 4.619 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Study Eye | 7.39 dBs | Standard Deviation 5.207 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 9.09 dBs | Standard Deviation 5.003 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 2.70 dBs | Standard Deviation 3.731 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.76 dBs | Standard Deviation 1.793 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Study Eye | 2.73 dBs | Standard Deviation 4.36 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Non-Study Eye | -0.44 dBs | Standard Deviation 1.723 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 2.77 dBs | Standard Deviation 4.598 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | 0.07 dBs | Standard Deviation 1.393 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 3.38 dBs | Standard Deviation 4.77 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.35 dBs | Standard Deviation 1.125 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | 0.30 dBs | Standard Deviation 1.654 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 2.79 dBs | Standard Deviation 4.663 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -0.44 dBs | Standard Deviation 1.078 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 1.16 dBs | Standard Deviation 5.66 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.66 dBs | Standard Deviation 0.702 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Study Eye | 1.55 dBs | Standard Deviation 5.886 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.08 dBs | Standard Deviation 0.834 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 2.54 dBs | Standard Deviation 6.317 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 0.10 dBs | Standard Deviation 5.723 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Study Eye | 7.38 dBs | Standard Deviation 3.095 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non-Study Eye | -0.54 dBs | Standard Deviation 0.636 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 8.98 dBs | Standard Deviation 3.583 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.24 dBs | Standard Deviation 0.5 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 1.00 dBs | Standard Deviation 6.862 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -1.04 dBs | Standard Deviation 1.292 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 3.74 dBs | Standard Deviation 3.931 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Non-Study Eye | 0.26 dBs | Standard Deviation 1.118 |
Secondary
Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry
MAIA microperimetry assessment was measured in dB using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Improvement in mean ensitivity in whole grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points of the grid as a whole (68 points). Here negative values indicate a decline in retinal sensitivity.
Time frame: Baseline, Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants who were randomized, under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 0.40 dBs | Standard Deviation 1.456 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Non-Study Eye | 0.30 dBs | Standard Deviation 1.111 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 0.91 dBs | Standard Deviation 1.389 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.13 dBs | Standard Deviation 1.283 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 0.46 dBs | Standard Deviation 1.064 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 3.32 dBs | Standard Deviation 2.539 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 0.32 dBs | Standard Deviation 1.301 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.16 dBs | Standard Deviation 0.743 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non- Study Eye | -0.41 dBs | Standard Deviation 1.15 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | 0.12 dBs | Standard Deviation 1.214 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -0.84 dBs | Standard Deviation 1.749 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Study Eye | 2.15 dBs | Standard Deviation 2.182 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Study Eye | 0.90 dBs | Standard Deviation 0.972 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 0.11 dBs | Standard Deviation 1.592 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 2.80 dBs | Standard Deviation 3.116 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Study Eye | 2.46 dBs | Standard Deviation 1.911 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 3.34 dBs | Standard Deviation 2.092 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | 1.60 dBs | Standard Deviation 2.225 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.46 dBs | Standard Deviation 1.044 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Study Eye | 2.34 dBs | Standard Deviation 2.353 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Non-Study Eye | -0.23 dBs | Standard Deviation 0.859 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 2.64 dBs | Standard Deviation 2.962 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.03 dBs | Standard Deviation 0.516 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 3.15 dBs | Standard Deviation 3.283 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.27 dBs | Standard Deviation 0.527 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non- Study Eye | -0.05 dBs | Standard Deviation 0.79 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 2.79 dBs | Standard Deviation 3.045 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -0.28 dBs | Standard Deviation 0.476 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Study Eye | 0.89 dBs | Standard Deviation 3.132 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Non-Study Eye | -0.50 dBs | Standard Deviation 0.632 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Study Eye | 1.18 dBs | Standard Deviation 3.367 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Non-Study Eye | -0.03 dBs | Standard Deviation 0.85 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Study Eye | 1.71 dBs | Standard Deviation 3.605 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 1: Study Eye | -0.07 dBs | Standard Deviation 3.898 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Study Eye | 3.84 dBs | Standard Deviation 2.138 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 9: Non- Study Eye | 0.09 dBs | Standard Deviation 0.544 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Baseline: Non-Study Eye | 4.47 dBs | Standard Deviation 2.331 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Non-Study Eye | -0.11 dBs | Standard Deviation 0.619 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 3: Study Eye | 0.24 dBs | Standard Deviation 3.962 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 12: Non-Study Eye | -0.35 dBs | Standard Deviation 1.004 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 6: Study Eye | 2.05 dBs | Standard Deviation 3.007 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Mean Sensitivity of the 68 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Change From Baseline at Month 2: Non-Study Eye | 0.13 dBs | Standard Deviation 0.668 |
Secondary
Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900
Visual field testing was performed to assess the volume of 30-degree hill vision, reported as dBs. RF=number of false positive responses + number of false negative responses/number of false positive presentations + number of false negative presentations\*100. If there are 0 responses, then RF value=0. RFpositive=number of false positive responses/number of false positive presentations\*100. If RF≤ 20% measurement is considered reliable. If 20% \< RF ≤ 25% and RFpositive ≤ 10% measurement is also considered reliable. Otherwise if 20% \< RF ≤ 25% and RFpositive \> 10%, or RF \> 25%, measurement is not reliable. Only reliable measurements were included for analysis of this outcome measure. Here negative values indicate decline in the volume of 30-degree hill vision.
Time frame: Baseline, Months 3, 6, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Baseline: Study Eye | 3.61 dBs | Standard Deviation 3.436 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Baseline: Non-Study Eye | 3.05 dBs | Standard Deviation 3.223 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Study Eye | 0.80 dBs | Standard Deviation 1.236 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Non-Study Eye | 0.52 dBs | Standard Deviation 1.315 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Study Eye | 0.13 dBs | Standard Deviation 0.499 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Non-Study Eye | 0.20 dBs | Standard Deviation 0.516 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Study Eye | -0.36 dBs | Standard Deviation 0.615 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Non-Study Eye | 0.29 dBs | Standard Deviation 0.487 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Study Eye | 0.63 dBs | Standard Deviation 1.162 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Study Eye | 0.26 dBs | Standard Deviation 1.164 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Non-Study Eye | 0.45 dBs | Standard Deviation 0.759 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Study Eye | 0.57 dBs | Standard Deviation 1.354 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Non-Study Eye | 0.30 dBs | Standard Deviation 0.665 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Baseline: Study Eye | 3.58 dBs | Standard Deviation 2.549 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Baseline: Non-Study Eye | 3.71 dBs | Standard Deviation 2.668 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Non-Study Eye | -0.10 dBs | Standard Deviation 0.781 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Study Eye | -0.01 dBs | Standard Deviation 5.288 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Baseline: Non-Study Eye | 6.23 dBs | Standard Deviation 2.956 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Baseline: Study Eye | 5.70 dBs | Standard Deviation 3.161 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Non-Study Eye | -0.02 dBs | Standard Deviation 1.11 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Study Eye | -1.91 dBs | Standard Deviation 1.498 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Non-Study Eye | 0.19 dBs | Standard Deviation 0.576 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Study Eye | -1.22 dBs | Standard Deviation 1.566 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of 30-Degree Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Non-Study Eye | -0.56 dBs | Standard Deviation 0.337 |
Secondary
Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900
Visual field testing was performed to assess the volume of full field of hill vision, reported as dBs. RF=number of false positive responses + number of false negative responses/number of false positive presentations + number of false negative presentations\*100. If there are 0 responses, then RF value=0. RFpositive=number of false positive responses/number of false positive presentations\*100. If RF≤ 20% measurement is considered reliable. If 20% \< RF ≤ 25% and RFpositive ≤ 10% measurement is also considered reliable. Otherwise if 20% \< RF ≤ 25% and RFpositive \> 10%, or RF \> 25%, measurement is not reliable. Only reliable measurements were included for analysis of this outcome measure. Here negative values indicate decline in volume of full field hill vision.
Time frame: Baseline, Months 3, 6, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Overall number of participants analyzed' signifies the number of participants with data available for analysis of outcome measure. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Baseline: Study Eye | 7.26 dBs | Standard Deviation 8.624 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Baseline: Non-Study Eye | 7.05 dBs | Standard Deviation 8.821 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Study Eye | 1.84 dBs | Standard Deviation 3.168 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Non-Study Eye | 1.36 dBs | Standard Deviation 2.46 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Study Eye | -0.35 dBs | Standard Deviation 1.461 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Non-Study Eye | 0.46 dBs | Standard Deviation 1.124 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Study Eye | -1.18 dBs | Standard Deviation 1.302 |
| Part 1: BIIB112 Dose 1 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Non-Study Eye | 0.66 dBs | Standard Deviation 1.193 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Study Eye | 1.26 dBs | Standard Deviation 3.327 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Study Eye | 0.81 dBs | Standard Deviation 3.709 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Non-Study Eye | 2.01 dBs | Standard Deviation 2.832 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Study Eye | 0.98 dBs | Standard Deviation 2.197 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Non-Study Eye | 0.99 dBs | Standard Deviation 2.324 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Baseline: Study Eye | 17.51 dBs | Standard Deviation 17.302 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Baseline: Non-Study Eye | 16.33 dBs | Standard Deviation 16.803 |
| Part 1: BIIB112 Dose 2 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Non-Study Eye | 0.28 dBs | Standard Deviation 2.736 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Study Eye | -0.10 dBs | Standard Deviation 4.059 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Baseline: Non-Study Eye | 21.08 dBs | Standard Deviation 17.56 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Baseline: Study Eye | 19.48 dBs | Standard Deviation 16.248 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 3: Non-Study Eye | 0.55 dBs | Standard Deviation 3.097 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Study Eye | -0.95 dBs | Standard Deviation 3.992 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Non-Study Eye | 1.38 dBs | Standard Deviation 2.526 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 6: Study Eye | 1.52 dBs | Standard Deviation 3.897 |
| Part 1: BIIB112 Dose 3 | Part 2: Change From Baseline in Volume of Full Field Hill of Vision Assessed by Octopus 900 | Change From Baseline at Month 12: Non-Study Eye | -0.91 dBs | Standard Deviation 2.001 |
Secondary
Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). An increase in the number of letters read correctly means that vision has improved. Percentage of eyes with a ≥10 letters increase from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 2: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 2: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 12: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 6: Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 1: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 2: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 3: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for BCVA | Month 1: Non-Study Eye | 10.0 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters increase from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 1: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 3: Study Eye | 25.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 3: Non-Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 6: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 6: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 9: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 9: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 12: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 1: Study Eye | 40.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 6: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 6: Study Eye | 44.4 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 12: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 9: Non-Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 3: Study Eye | 40.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 9: Study Eye | 37.5 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 9: Non-Study Eye | 14.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 6: Study Eye | 14.7 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 12: Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 9: Study Eye | 28.6 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 1: Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letter Increase From Baseline for LLVA | Month 3: Study Eye | 30.0 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters loss from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 2: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 9.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 2: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 9.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 8.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 8.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 2: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥10 letters loss from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 18.2 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 18.2 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥10 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters increase from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 2: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 2: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 1: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 2: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 3: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters increase from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. Number analyzed signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 12: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 1: Study Eye | 40.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 6: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 3: Study Eye | 40.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 9: Study Eye | 25.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 6: Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 12: Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 9: Study Eye | 28.6 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 1: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 1: Non-Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letter Increase From Baseline for LLVA | Month 3: Study Eye | 30.0 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters loss from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 2: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 2: Non- Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 2: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 2: Non- Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 2: Non- Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 2: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 8.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 8.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥15 letters loss from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 18.2 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 9.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥15 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 33.3 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters increase from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 1: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 2: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 3: Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 6: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 12: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 1: Study Eye | 60.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 6: Study Eye | 44.4 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 9: Study Eye | 37.5 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 1: Non-Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 12: Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 2: Study Eye | 60.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 3: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 2: Non-Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 3: Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 9: Non-Study Eye | 42.9 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 3: Non-Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 6: Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 6: Non-Study Eye | 25.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 12: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 1: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 1: Non-Study Eye | 40.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 2: Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for BCVA | Month 12: Non-Study Eye | 28.6 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters increase from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 1: Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 1: Non-Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 3: Study Eye | 37.5 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 3: Non-Study Eye | 25.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 6: Study Eye | 44.4 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 6: Non-Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 9: Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 9: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 12: Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 12: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 12: Study Eye | 44.4 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 1: Study Eye | 60.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 6: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 6: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 1: Non-Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 12: Non-Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 9: Non-Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 3: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 9: Study Eye | 62.5 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 3: Non-Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 9: Non-Study Eye | 42.9 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 3: Non-Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 6: Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 6: Non-Study Eye | 25.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 12: Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 9: Study Eye | 57.1 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 1: Study Eye | 40.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 1: Non-Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letter Increase From Baseline for LLVA | Month 3: Study Eye | 30.0 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters loss from baseline for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 2: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 11.1 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 9.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 9.1 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 18.2 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 2: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 18.2 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 2: Non-Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 2: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 6: Non-Study Eye | 10.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 9: Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 2: Study Eye | 40.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for BCVA | Month 12: Non-Study Eye | 0.0 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a ≥5 letters loss from baseline for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 12.5 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 37.5 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 55.6 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 55.6 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 44.4 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 18.2 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 50.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 20.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 36.4 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 40.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 18.2 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 22.2 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 9.1 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 6: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Study Eye | 40.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 9: Study Eye | 33.3 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Study Eye | 41.7 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 12: Non-Study Eye | 30.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 1: Non-Study Eye | 0.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With a ≥5 Letters Loss From Baseline for LLVA | Month 3: Study Eye | 41.7 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA
BCVA was assessed for both eyes using the ETDRS VA chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a change from baseline of ≥ -5 letters for BCVA were reported for study and non-study eyes.
Time frame: Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 1: Study Eye | 88.9 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 1: Non-Study Eye | 88.9 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 2: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 2: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 3: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 6: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 6: Non-Study Eye | 77.8 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 9: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 9: Non-Study Eye | 77.8 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 12: Study Eye | 88.9 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 12: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 12: Non-Study Eye | 88.9 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 1: Study Eye | 90.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 6: Study Eye | 88.9 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 9: Study Eye | 75.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 1: Non-Study Eye | 90.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 3: Non-Study Eye | 90.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 12: Study Eye | 77.8 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 2: Study Eye | 80.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 6: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 3: Study Eye | 80.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 2: Non-Study Eye | 90.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 2: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 3: Study Eye | 70.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 6: Study Eye | 75.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 6: Non-Study Eye | 87.5 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 12: Study Eye | 87.5 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 1: Study Eye | 70.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 1: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 9: Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 2: Study Eye | 60.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for BCVA | Month 12: Non-Study Eye | 100.0 percentage of eyes |
Secondary
Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA
LLVA was measured by placing a 2.0-log-unit neutral density filter over the front of each eye and having the participant read the normally illuminated ETDRS chart. Initially, letters were read at a distance of 4 meters from the chart. If \<20 letters were read at 4 meters, testing at 1 meter was performed. The lower the number of letters read correctly on the eye chart, the worse the vision (or VA). Percentage of eyes with a change from baseline of ≥ -5 letters for LLVA were reported for study and non-study eyes.
Time frame: Months 1, 3, 6, 9, and 12
Population: ITT analysis set included all participants that were randomized under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 1: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 1: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 3: Study Eye | 87.5 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 3: Non-Study Eye | 62.5 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 6: Study Eye | 77.8 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 6: Non-Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 9: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 9: Non-Study Eye | 44.4 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 12: Study Eye | 44.4 percentage of eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 12: Non-Study Eye | 55.6 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 12: Study Eye | 66.7 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 1: Study Eye | 80.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 6: Non-Study Eye | 44.4 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 6: Study Eye | 77.8 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 1: Non-Study Eye | 60.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 12: Non-Study Eye | 55.6 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 9: Non-Study Eye | 62.5 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 3: Study Eye | 80.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 9: Study Eye | 75.0 percentage of eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 9: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 3: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 6: Study Eye | 75.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 6: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 12: Study Eye | 75.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 9: Study Eye | 71.4 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 1: Study Eye | 70.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 12: Non-Study Eye | 62.5 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 1: Non-Study Eye | 100.0 percentage of eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Eyes With Change From Baseline >-5 Letters for LLVA | Month 3: Study Eye | 60.0 percentage of eyes |
Secondary
Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry
MAIA microperimetry assessment was measured in dBs using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' is assigned a value of '-1' by MAIA in the calculation. Improvement in mean sensitivity in center grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points out of the 16 central points.
Time frame: Months 1, 2, 3, 6, and 9
Population: ITT analysis set included all participants who were randomized, under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 22.2 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 12.5 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 22.2 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 2 | 22.2 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 22.2 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 30.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 30.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 2 | 30.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 28.6 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 42.9 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 62.5 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 40.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 60.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 16 Central Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 2 | 50.0 percentage of study eyes |
Secondary
Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry
MAIA microperimetry assessment was measured in dBs using a 10-2 grid of 68 points. Each point was labelled as '\< 0', '0' or a positive integer. The point labelled as '\< 0' was assigned a value of '-1' by MAIA in the calculation. Improvement in mean sensitivity in whole grid was defined as an increase from baseline of 7 or more dBs in any 5 or more points of the grid as a whole (68 points).
Time frame: Months 1, 2, 3, 6, 9, and 12
Population: ITT analysis set included all participants who were randomized, under the 3-arm randomization schedules. 'Number analyzed' signifies the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 2 | 22.2 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 25.0 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 1 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 33.3 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 62.5 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 60.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 77.8 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 85.7 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 2 | 80.0 percentage of study eyes |
| Part 1: BIIB112 Dose 2 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 80.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 2 | 80.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 3 | 70.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 12 | 62.5 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 6 | 100.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 1 | 40.0 percentage of study eyes |
| Part 1: BIIB112 Dose 3 | Part 2: Percentage of Study Eyes With ≥7 dB Improvement From Baseline at ≥5 Points Out of the 68 Loci Points of the 10-2 Grid Assessed by MAIA Microperimetry | Month 9 | 71.4 percentage of study eyes |