Choroideremia
Conditions
Keywords
NightstaRx, NSR-REP1, CHM, Gene Therapy, AAV, REP1, Timrepigene Emparvovec
Brief summary
The objective of the study is to evaluate the safety of bilateral, sequential sub-retinal administration of a single dose of BIIB111 in adult male participants with Choroideremia (CHM).
Detailed description
This study was previously posted by NightstaRx Ltd. In October 2020, sponsorship of the trial was transferred to Biogen.
Interventions
DRUGBIIB111
Administered as specified in the treatment arm.
Sponsors
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Are willing and able to give informed consent for participation in the study to have both eyes treated. 2. Have documentation of a genetically-confirmed diagnosis of CHM. 3. Have active disease clinically visible within the macular region of both eyes. 4. Have a BCVA of ≥34 ETDRS letters (20/200 or better Snellen acuity) in both eyes, or in the untreated eye, if the other eye was previously treated with BIIB111\* \*If previously treated with BIIB111 in an antecedent study, participants may be eligible for participation following Sponsor approval. 5. For participants who received treatment with BIIB111 in an antecedent study, have biological samples available to complete an adequate immunology profile. Key
Exclusion criteria
1. Have a history of amblyopia or inflammatory disorder in either eye. 2. Are unwilling to use barrier contraception methods or abstain from sexual intercourse for a period of 3 months following treatment with BIIB111 in either eye. 3. Have had previous intraocular surgery performed within 3 months of the Screening Visit in either eye. 4. Have any other significant ocular or non-ocular disease/disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the results of the study or the participant's ability to participate in the study. This includes but is not limited to a potential participants: * with a contraindication to oral corticosteroid (e.g., prednisolone/prednisone) * with clinically significant cataract in either eye * who, in the clinical opinion of the Investigator, is not an appropriate candidate for sub-retinal surgery. 5. Have participated in another research study involving an investigational product in the past 12 weeks or received a gene/cell-based therapy at any time previously, except if treated within an antecedent study with BIIB111. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vital Signs: Change From Baseline in Pulse Rate at Month 12 | Baseline, Month 12 | Change from baseline in pulse rate (beats per minute) were reported. |
| AF: Mean Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Month 12 | Fundus AF was used to assess the distance from foveal center to nearest border of preserved AF. |
| Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Month 12 | Number of participants with RPE hyperplasia are reported for severity grades: mild, moderate, severe. |
| Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Month 12 | Number of participants with retinal arteriolar narrowing are reported for severity grades: mild, moderate, severe. |
| Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Month 12 | Number of participants with retinal vessel sheathing are reported for severity grades: mild, moderate, severe. |
| Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Month 12 | Number of participants with optic atrophy/pallor are reported for severity grades: mild, moderate, severe. |
| Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Month 12 | Number of participants with optic disc swelling are reported for severity grades: mild, moderate, severe. |
| Microperimetry: Retinal Mean Sensitivity at Month 12 | Month 12 | Microperimetry was conducted to assess retinal mean sensitivity within the macula. Retinal mean sensitivity to light was measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers (decibels) indicate higher retinal sensitivity. |
| Microperimetry: Bivariate Contour Ellipse Area 63% at Month 12 | Month 12 | Microperimetry was conducted to assess bivariate contour ellipse area 63%. |
| Microperimetry: Bivariate Contour Ellipse Area 95% at Month 12 | Month 12 | Microperimetry was conducted to assess bivariate contour ellipse area 95%. |
| Microperimetry: Fixation Losses (in Percentage) at Month 12 | Month 12 | Microperimetry was conducted to assess fixation losses (in percentage) which samples the optic nerve blind spot for positive responses. |
| Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years) | An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug/surgical procedure, whether or not related to the investigational product or with the surgical procedure. TEAEs are defined as AEs starting on or after the day of the first surgery. |
| Number of Participants With Vector Shedding Post-treatment at Month 3 | Baseline, at Month 3 | Tears (for both eyes- oculus dexter \[OD\] and oculus sinister \[OS\]), blood, urine and saliva samples were collected and tested using an appropriate assay for evidence of vector shedding. Participants with positive result for vector shredding post treatment are reported. |
| Number of Participants With Anti-drug Antibodies Post-treatment at Month 12 | Month 12 | Participants with antibodies to the REP-1 transgenic product are reported. |
| Vital Signs: Change From Baseline in Blood Pressure at Month 12 | Baseline, Month 12 | Change from baseline in Systolic and diastolic blood pressures (BP) (millimeters of mercury \[mmHg\]) were reported. |
| Mean Best-Corrected Visual Acuity (BCVA) as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) Chart in Letters at Month 12 | Month 12 | BCVA was assessed for both eyes using the ETDRS visual acuity (VA) chart. BCVA test should be performed prior to pupil dilation, and distance refraction should be carried out before BCVA is measured. Initially, letters are read at a distance of 4 meters from the chart. If \<20 letters are read at 4 meters, testing at 1 meter should be performed. BCVA is reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters) in the study eyes. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. |
| Ophthalmic Examination Assessment: Mean Intraocular Pressure (IOP) at Month 12 | Month 12 | IOP, the fluid pressure inside the eye was measured and reported in millimeters mercury (mmHg). |
| Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Baseline, Month 12 | Slit lamp examinations of study eyes included examination of Cornea, Conjunctiva, Iris, Lens, and Anterior Segment. |
| Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Baseline, Month 12 | Dilated Ophthalmoscopy examination of study eyes included examination of Vitreous, Macula, Peripheral retina, Choroid, and Optic nerve. |
| Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Month 12 | The following lens opacity grades are reported for categories 1-4: Nuclear Opalescence grade, Nuclear Color grade, Cortical Cataract grade, and Posterior Cataract grade. Opacification severity is graded on a decimal scale, scores can range from 0.1 (no opacity) to 6.9 (maximum opacity) for the Nuclear Opalescence and Nuclear Color grades; and scores can range from 0.1 (lens clear) to 5.9 (lens unclear) for the Cortical and Posterior Cataract grades. Category 1 includes values 1, 1.0 and 0.x, Category 2 includes values 2, 2.0 and 1.x, Category 3 includes values 3, 3.0 and 2.x, and Category 4 includes values 4, 4.0, 3.x and any values above 4. For each opacification type the higher grading scores indicate greater severity. |
| Spectral Domain Optical Coherence Tomography (SD-OCT): Foveal Subfield Thickness at Month 12 | Month 12 | SD-OCT was used to assess change in foveal subfield thickness. The measurements were taken after dilation of the participant's pupil. |
| SD-OCT: Total Macular Volume at Month 12 | Month 12 | SD-OCT was used to assess change in total macular volume. The measurements were taken after dilation of the participant's pupil. |
| SD-OCT: Central Horizontal Ellipsoid Width at Month 12 | Month 12 | SD-OCT was used to assess change in central horizontal ellipsoid width. The measurements were taken after dilation of the participant's pupil. |
| SD-OCT: Central Ellipsoid Area at Month 12 | Month 12 | SD-OCT was used to assess change in central ellipsoid area. The measurements were taken after dilation of the participant's pupil. |
| SD-OCT: Square Root of Central Ellipsoid Area at Month 12 | Month 12 | SD-OCT was used to assess change in square root of central ellipsoid area. The measurements were taken after dilation of the participant's pupil. |
| SD-OCT: Choroidal Thickness at Foveal Center at Month 12 | Month 12 | SD-OCT was used to assess change in choroidal thickness. The measurements were taken after dilation of the participant's pupil. |
| Fundus Autofluorescence (AF): Mean Total Area of Preserved Autofluorescence at Month 12 | Month 12 | Fundus AF was used to assess the total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper autofluorescence (hyper AF) compared with the background areas of surrounding atrophy. |
| AF: Mean Square Root of Total Area of Preserved AF at Month 12 | Month 12 | Fundus AF was used to assess the square root of total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper AF compared with the background areas of surrounding atrophy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AF: Change From Baseline in Total Area of Preserved Autofluorescence at Month 12 | Baseline, Month 12 | Fundus AF was used to assess change in total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper autofluorescence (hyper AF) compared with the background areas of surrounding atrophy. Here negative values indicate decline in total area of preserved autofluoroscence. |
| AF: Change From Baseline in Square Root of Total Area of Preserved AF at Month 12 | Baseline, Month 12 | Fundus AF was used to assess change in square root of total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper AF compared with the background areas of surrounding atrophy. Here negative values indicate decline in total area of preserved autofluoroscence. |
| AF: Change From Baseline in Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Baseline, Month 12 | Fundus Autofluoroscence was used to assess change in distance from foveal center to nearest border of preserved autofluoroscence. Here negative values indicate decline in total area of preserved autofluoroscence. |
| SD-OCT: Change From Baseline in Foveal Subfield Thickness at Month 12 | Baseline, Month 12 | SD-OCT was used to assess change in foveal subfield thickness. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in foveal subfield thickness. |
| SD-OCT: Change From Baseline in Total Macular Volume at Month 12 | Baseline, Month 12 | SD-OCT was used to assess change in total macular volume. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in total macular volume. |
| SD-OCT: Change From Baseline in the Central Horizontal Ellipsoid Width at Month 12 | Baseline, Month 12 | 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 decline in central horizontal ellipsoid width. |
| SD-OCT: Change From Baseline in Central Ellipsoid Area at Month 12 | Baseline, Month 12 | 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 decline in central ellipsoid area. |
| SD-OCT: Change From Baseline in Square Root of Central Ellipsoid Area at Month 12 | Baseline, Month 12 | SD-OCT was used to assess change in square root of central ellipsoid area. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in square root of central ellipsoid area. |
| SD-OCT: Change From Baseline in the Choroidal Thickness at Foveal Center at Month 12 | Baseline, Month 12 | SD-OCT was used to assess change in choroidal thickness. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in choroidal thickness. |
| Microperimetry: Change From Baseline in Retinal Mean Sensitivity at Month 12 | Baseline, Month 12 | Microperimetry was conducted to assess change in retinal mean sensitivity within the macula. Retinal mean sensitivity to light was measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers (decibels) indicate higher retinal sensitivity. A negative change from baseline indicates decline in retinal sensitivity. |
| Microperimetry: Change From Baseline in Bivariate Contour Ellipse Area 63% at Month 12 | Baseline, Month 12 | Microperimetry was conducted to assess change in bivariate contour ellipse area 63%. A negative change from baseline indicates decline in bivariate contour ellipse area 63%. |
| Microperimetry: Change From Baseline in the Bivariate Contour Ellipse Area 95% at Month 12 | Baseline, Month 12 | Microperimetry was conducted to assess change in bivariate contour ellipse area 95%. A negative change from baseline indicates decline in bivariate contour ellipse area 95%. |
| Microperimetry: Change From Baseline in Fixation Losses (in Percentage) at Month 12 | Baseline, Month 12 | Microperimetry was conducted to assess change in fixation losses (in percentage) which samples the optic nerve blind spot for positive responses. A negative change from baseline indicates decline in fixation losses. |
| Change From Baseline in BCVA as Measured by the ETDRS Chart | Baseline, Month 12 | BCVA was assessed for both eyes using the ETDRS VA chart. BCVA test should be performed prior to pupil dilation, and distance refraction should be carried out before BCVA is measured. Initially, letters are read at a distance of 4 meters from the chart. If \<20 letters are read at 4 meters, testing at 1 meter should be performed. BCVA is reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters) in the study eyes. 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. |
Countries
France, Germany, United States
Participant flow
Recruitment details
Participants were enrolled at the investigative sites in France, Germany, and the United States from 29 November 2017 to 29 June 2022.
Pre-assignment details
A total of 66 unique male participants with Choroideremia were treated in the study. Of which 60 participants were treated in treatment Period 1 and 50 participants completed Period 1. 50 participants from Period 1 enrolled in Period 2 along with 6 unique participants who were treated in the first eye in a previous study (20150371 \[NCT02553135\], THOR-TUE-01 \[NCT02671539\]). 53 participants completed Period 2.
Participants by arm
| Arm | Count |
|---|---|
| All Treated Participants After vitrectomy and retinal detachment in the study eye 1 and study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1 and Period 2 respectively. | 66 |
| Total | 66 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Period 1(Day 1 up to Month 12) | Reason not Specified | 2 | 0 |
| Treatment Period 1(Day 1 up to Month 12) | Serious Adverse Event | 4 | 0 |
| Treatment Period 1(Day 1 up to Month 12) | Site Terminated by Sponsor | 2 | 0 |
| Treatment Period 1(Day 1 up to Month 12) | Withdrawal by Subject | 2 | 0 |
| Treatment Period 2 (Month13 to Month24) | Death | 0 | 1 |
| Treatment Period 2 (Month13 to Month24) | Reason not Specified | 0 | 2 |
Baseline characteristics
| Characteristic | All Treated Participants |
|---|---|
| Age, Continuous | 36.7 Years STANDARD_DEVIATION 13.57 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 60 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 65 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 1 / 56 |
| other Total, other adverse events | 59 / 60 | 53 / 56 |
| serious Total, serious adverse events | 12 / 60 | 8 / 56 |
Outcome results
Primary
AF: Mean Distance From Foveal Center to Nearest Border of Preserved AF at Month 12
Fundus AF was used to assess the distance from foveal center to nearest border of preserved AF.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | AF: Mean Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Study Eye 1 | 423.133 mm | Standard Deviation 559.1529 |
| Treatment Period 1: BIIB111 | AF: Mean Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Study Eye 2 | 539.600 mm | Standard Deviation 602.6063 |
| Treatment Period 2: BIIB111 | AF: Mean Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Study Eye 1 | 370.245 mm | Standard Deviation 733.1618 |
| Treatment Period 2: BIIB111 | AF: Mean Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Study Eye 2 | 525.212 mm | Standard Deviation 688.7141 |
Primary
AF: Mean Square Root of Total Area of Preserved AF at Month 12
Fundus AF was used to assess the square root of total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper AF compared with the background areas of surrounding atrophy.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | AF: Mean Square Root of Total Area of Preserved AF at Month 12 | Study Eye 1 | 2.4358 mm | Standard Deviation 1.13836 |
| Treatment Period 1: BIIB111 | AF: Mean Square Root of Total Area of Preserved AF at Month 12 | Study Eye 2 | 2.6214 mm | Standard Deviation 1.17348 |
| Treatment Period 2: BIIB111 | AF: Mean Square Root of Total Area of Preserved AF at Month 12 | Study Eye 1 | 2.6149 mm | Standard Deviation 1.37197 |
| Treatment Period 2: BIIB111 | AF: Mean Square Root of Total Area of Preserved AF at Month 12 | Study Eye 2 | 2.7550 mm | Standard Deviation 1.46149 |
Primary
Fundus Autofluorescence (AF): Mean Total Area of Preserved Autofluorescence at Month 12
Fundus AF was used to assess the total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper autofluorescence (hyper AF) compared with the background areas of surrounding atrophy.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified parameter.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Fundus Autofluorescence (AF): Mean Total Area of Preserved Autofluorescence at Month 12 | Study Eye 1 | 7.130 mm^2 | Standard Deviation 6.2326 |
| Treatment Period 1: BIIB111 | Fundus Autofluorescence (AF): Mean Total Area of Preserved Autofluorescence at Month 12 | Study Eye 2 | 8.157 mm^2 | Standard Deviation 7.4969 |
| Treatment Period 2: BIIB111 | Fundus Autofluorescence (AF): Mean Total Area of Preserved Autofluorescence at Month 12 | Study Eye 1 | 8.682 mm^2 | Standard Deviation 9.8972 |
| Treatment Period 2: BIIB111 | Fundus Autofluorescence (AF): Mean Total Area of Preserved Autofluorescence at Month 12 | Study Eye 2 | 9.682 mm^2 | Standard Deviation 11.0688 |
Primary
Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity
Number of participants with optic atrophy/pallor are reported for severity grades: mild, moderate, severe.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Mild: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Mild: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Moderate: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Moderate: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Severe: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Severe: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Severe: Study Eye 1 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Mild: Study Eye 1 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Moderate: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Mild: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Severe: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Atrophy/Pallor as Per Severity | Moderate: Study Eye 1 | 0 Participants |
Primary
Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity
Number of participants with optic disc swelling are reported for severity grades: mild, moderate, severe.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Mild: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Mild: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Moderate: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Moderate: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Severe: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Severe: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Severe: Study Eye 1 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Mild: Study Eye 1 | 1 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Moderate: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Mild: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Severe: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Optic Disc Swelling as Per Severity | Moderate: Study Eye 1 | 0 Participants |
Primary
Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity
Number of participants with retinal arteriolar narrowing are reported for severity grades: mild, moderate, severe.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Mild: Study Eye 1 | 13 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Mild: Study Eye 2 | 12 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Moderate: Study Eye 1 | 1 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Moderate: Study Eye 2 | 2 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Severe: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Severe: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Severe: Study Eye 1 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Mild: Study Eye 1 | 37 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Moderate: Study Eye 2 | 10 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Mild: Study Eye 2 | 36 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Severe: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Arteriolar Narrowing as Per Severity | Moderate: Study Eye 1 | 10 Participants |
Primary
Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity
Number of participants with RPE hyperplasia are reported for severity grades: mild, moderate, severe.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Mild: Study Eye 1 | 7 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Mild: Study Eye 2 | 9 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Moderate: Study Eye 1 | 8 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Moderate: Study Eye 2 | 6 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Severe: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Severe: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Severe: Study Eye 1 | 2 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Mild: Study Eye 1 | 26 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Moderate: Study Eye 2 | 23 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Mild: Study Eye 2 | 23 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Severe: Study Eye 2 | 2 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Pigment Epithelium (RPE) Hyperplasia as Per Severity | Moderate: Study Eye 1 | 21 Participants |
Primary
Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity
Number of participants with retinal vessel sheathing are reported for severity grades: mild, moderate, severe.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Mild: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Mild: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Moderate: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Moderate: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Severe: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Severe: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Severe: Study Eye 1 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Mild: Study Eye 1 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Moderate: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Mild: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Severe: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Fundus Photography: Number of Participants With Retinal Vessel Sheathing as Per Severity | Moderate: Study Eye 1 | 0 Participants |
Primary
Mean Best-Corrected Visual Acuity (BCVA) as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) Chart in Letters at Month 12
BCVA was assessed for both eyes using the ETDRS visual acuity (VA) chart. BCVA test should be performed prior to pupil dilation, and distance refraction should be carried out before BCVA is measured. Initially, letters are read at a distance of 4 meters from the chart. If \<20 letters are read at 4 meters, testing at 1 meter should be performed. BCVA is reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters) in the study eyes. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Mean Best-Corrected Visual Acuity (BCVA) as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) Chart in Letters at Month 12 | Study Eye 1 | 68.0 letters | Standard Deviation 25.18 |
| Treatment Period 1: BIIB111 | Mean Best-Corrected Visual Acuity (BCVA) as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) Chart in Letters at Month 12 | Study Eye 2 | 82.3 letters | Standard Deviation 8.67 |
| Treatment Period 2: BIIB111 | Mean Best-Corrected Visual Acuity (BCVA) as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) Chart in Letters at Month 12 | Study Eye 1 | 76.5 letters | Standard Deviation 13.78 |
| Treatment Period 2: BIIB111 | Mean Best-Corrected Visual Acuity (BCVA) as Measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) Chart in Letters at Month 12 | Study Eye 2 | 81.2 letters | Standard Deviation 10.82 |
Primary
Microperimetry: Bivariate Contour Ellipse Area 63% at Month 12
Microperimetry was conducted to assess bivariate contour ellipse area 63%.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Microperimetry: Bivariate Contour Ellipse Area 63% at Month 12 | Study Eye 1 | 7.91 square degrees (deg^2) | Standard Deviation 13.287 |
| Treatment Period 1: BIIB111 | Microperimetry: Bivariate Contour Ellipse Area 63% at Month 12 | Study Eye 2 | 1.45 square degrees (deg^2) | Standard Deviation 1.874 |
| Treatment Period 2: BIIB111 | Microperimetry: Bivariate Contour Ellipse Area 63% at Month 12 | Study Eye 1 | 2.09 square degrees (deg^2) | Standard Deviation 4.701 |
| Treatment Period 2: BIIB111 | Microperimetry: Bivariate Contour Ellipse Area 63% at Month 12 | Study Eye 2 | 1.92 square degrees (deg^2) | Standard Deviation 5.51 |
Primary
Microperimetry: Bivariate Contour Ellipse Area 95% at Month 12
Microperimetry was conducted to assess bivariate contour ellipse area 95%.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Microperimetry: Bivariate Contour Ellipse Area 95% at Month 12 | Study Eye 1 | 23.69 deg^2 | Standard Deviation 39.857 |
| Treatment Period 1: BIIB111 | Microperimetry: Bivariate Contour Ellipse Area 95% at Month 12 | Study Eye 2 | 4.35 deg^2 | Standard Deviation 5.624 |
| Treatment Period 2: BIIB111 | Microperimetry: Bivariate Contour Ellipse Area 95% at Month 12 | Study Eye 1 | 6.27 deg^2 | Standard Deviation 14.106 |
| Treatment Period 2: BIIB111 | Microperimetry: Bivariate Contour Ellipse Area 95% at Month 12 | Study Eye 2 | 5.76 deg^2 | Standard Deviation 16.518 |
Primary
Microperimetry: Fixation Losses (in Percentage) at Month 12
Microperimetry was conducted to assess fixation losses (in percentage) which samples the optic nerve blind spot for positive responses.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Microperimetry: Fixation Losses (in Percentage) at Month 12 | Study Eye 1 | 9.0 percentage (%) | Standard Deviation 12.45 |
| Treatment Period 1: BIIB111 | Microperimetry: Fixation Losses (in Percentage) at Month 12 | Study Eye 2 | 4.0 percentage (%) | Standard Deviation 8.94 |
| Treatment Period 2: BIIB111 | Microperimetry: Fixation Losses (in Percentage) at Month 12 | Study Eye 1 | 2.2 percentage (%) | Standard Deviation 7.2 |
| Treatment Period 2: BIIB111 | Microperimetry: Fixation Losses (in Percentage) at Month 12 | Study Eye 2 | 5.0 percentage (%) | Standard Deviation 9.17 |
Primary
Microperimetry: Retinal Mean Sensitivity at Month 12
Microperimetry was conducted to assess retinal mean sensitivity within the macula. Retinal mean sensitivity to light was measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers (decibels) indicate higher retinal sensitivity.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Microperimetry: Retinal Mean Sensitivity at Month 12 | Study Eye 1 | 4.05 decibels (dB) | Standard Deviation 4.565 |
| Treatment Period 1: BIIB111 | Microperimetry: Retinal Mean Sensitivity at Month 12 | Study Eye 2 | 5.41 decibels (dB) | Standard Deviation 5.239 |
| Treatment Period 2: BIIB111 | Microperimetry: Retinal Mean Sensitivity at Month 12 | Study Eye 1 | 5.93 decibels (dB) | Standard Deviation 6.991 |
| Treatment Period 2: BIIB111 | Microperimetry: Retinal Mean Sensitivity at Month 12 | Study Eye 2 | 6.37 decibels (dB) | Standard Deviation 6.72 |
Primary
Number of Participants With Anti-drug Antibodies Post-treatment at Month 12
Participants with antibodies to the REP-1 transgenic product are reported.
Time frame: Month 12
Population: The immunogenicity analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2 with baseline sample and at least one post-surgery sample evaluable for immunogenicity.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Period 1: BIIB111 | Number of Participants With Anti-drug Antibodies Post-treatment at Month 12 | 0 Participants |
| Treatment Period 2: BIIB111 | Number of Participants With Anti-drug Antibodies Post-treatment at Month 12 | 0 Participants |
Primary
Number of Participants With Vector Shedding Post-treatment at Month 3
Tears (for both eyes- oculus dexter \[OD\] and oculus sinister \[OS\]), blood, urine and saliva samples were collected and tested using an appropriate assay for evidence of vector shedding. Participants with positive result for vector shredding post treatment are reported.
Time frame: Baseline, at Month 3
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified parameter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: BIIB111 | Number of Participants With Vector Shedding Post-treatment at Month 3 | Tears OS | 0 Participants |
| Treatment Period 1: BIIB111 | Number of Participants With Vector Shedding Post-treatment at Month 3 | Saliva | 0 Participants |
| Treatment Period 1: BIIB111 | Number of Participants With Vector Shedding Post-treatment at Month 3 | Blood | 0 Participants |
| Treatment Period 1: BIIB111 | Number of Participants With Vector Shedding Post-treatment at Month 3 | Urine | 0 Participants |
| Treatment Period 1: BIIB111 | Number of Participants With Vector Shedding Post-treatment at Month 3 | Tears OD | 0 Participants |
| Treatment Period 2: BIIB111 | Number of Participants With Vector Shedding Post-treatment at Month 3 | Urine | 0 Participants |
| Treatment Period 2: BIIB111 | Number of Participants With Vector Shedding Post-treatment at Month 3 | Tears OD | 0 Participants |
| Treatment Period 2: BIIB111 | Number of Participants With Vector Shedding Post-treatment at Month 3 | Tears OS | 0 Participants |
| Treatment Period 2: BIIB111 | Number of Participants With Vector Shedding Post-treatment at Month 3 | Blood | 0 Participants |
| Treatment Period 2: BIIB111 | Number of Participants With Vector Shedding Post-treatment at Month 3 | Saliva | 0 Participants |
Primary
Ophthalmic Examination Assessment: Mean Intraocular Pressure (IOP) at Month 12
IOP, the fluid pressure inside the eye was measured and reported in millimeters mercury (mmHg).
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Mean Intraocular Pressure (IOP) at Month 12 | Study Eye 1 | 13.5 mmHg | Standard Deviation 3.09 |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Mean Intraocular Pressure (IOP) at Month 12 | Study Eye 2 | 14.9 mmHg | Standard Deviation 2.5 |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Mean Intraocular Pressure (IOP) at Month 12 | Study Eye 1 | 13.5 mmHg | Standard Deviation 3.12 |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Mean Intraocular Pressure (IOP) at Month 12 | Study Eye 2 | 13.5 mmHg | Standard Deviation 3.55 |
Primary
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy
Dilated Ophthalmoscopy examination of study eyes included examination of Vitreous, Macula, Peripheral retina, Choroid, and Optic nerve.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified category at specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Vitreous: Study Eye 1: Baseline | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Vitreous: Study Eye 1: Month 12 | 1 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Vitreous: Study Eye 2: Baseline | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Vitreous: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Macula: Study Eye 1: Baseline | 57 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Macula: Study Eye 1: Month 12 | 15 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Macula: Study Eye 2: Baseline | 58 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Macula: Study Eye 2: Month 12 | 15 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Peripheral Retina: Study Eye 1: Baseline | 58 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Peripheral Retina: Study Eye 1: Month 12 | 15 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Peripheral Retina: Study Eye 2: Baseline | 58 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Peripheral Retina: Study Eye 2: Month 12 | 15 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Choroid: Study Eye 1: Baseline | 58 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Choroid: Study Eye 1: Month 12 | 15 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Choroid: Study Eye 2: Baseline | 58 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Choroid: Study Eye 2: Month 12 | 15 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Optic Nerve: Study Eye 1: Baseline | 5 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Optic Nerve: Study Eye 1: Month 12 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Optic Nerve: Study Eye 2: Baseline | 6 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Optic Nerve: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Optic Nerve: Study Eye 1: Month 12 | 3 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Vitreous: Study Eye 1: Baseline | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Peripheral Retina: Study Eye 2: Baseline | 54 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Vitreous: Study Eye 1: Month 12 | 1 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Choroid: Study Eye 2: Month 12 | 51 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Vitreous: Study Eye 2: Baseline | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Peripheral Retina: Study Eye 2: Month 12 | 51 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Vitreous: Study Eye 2: Month 12 | 1 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Optic Nerve: Study Eye 2: Month 12 | 4 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Macula: Study Eye 1: Baseline | 54 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Choroid: Study Eye 1: Baseline | 54 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Macula: Study Eye 1: Month 12 | 51 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Optic Nerve: Study Eye 1: Baseline | 4 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Macula: Study Eye 2: Baseline | 54 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Choroid: Study Eye 1: Month 12 | 51 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Macula: Study Eye 2: Month 12 | 51 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Optic Nerve: Study Eye 2: Baseline | 4 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Peripheral Retina: Study Eye 1: Baseline | 54 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Choroid: Study Eye 2: Baseline | 54 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Dilated Ophthalmoscopy | Peripheral Retina: Study Eye 1: Month 12 | 51 Participants |
Primary
Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination
Slit lamp examinations of study eyes included examination of Cornea, Conjunctiva, Iris, Lens, and Anterior Segment.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified category at specified timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Cornea: Study Eye 1: Baseline | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Cornea: Study Eye 1: Month 12 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Cornea: Study Eye 2: Baseline | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Cornea: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Conjunctiva: Study Eye 1: Baseline | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Conjunctiva: Study Eye 1: Month 12 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Conjunctiva: Study Eye 2: Baseline | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Conjunctiva: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Iris: Study Eye 1: Baseline | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Iris: Study Eye 1: Month 12 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Iris: Study Eye 2: Baseline | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Iris: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Lens: Study Eye 1: Baseline | 2 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Lens: Study Eye 1: Month 12 | 1 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Lens: Study Eye 2: Baseline | 2 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Lens: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Anterior Segment: Study Eye 1: Baseline | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Anterior Segment: Study Eye 1: Month 12 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Anterior Segment: Study Eye 2: Baseline | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Anterior Segment: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Anterior Segment: Study Eye 1: Month 12 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Cornea: Study Eye 1: Baseline | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Iris: Study Eye 2: Baseline | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Cornea: Study Eye 1: Month 12 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Lens: Study Eye 2: Month 12 | 3 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Cornea: Study Eye 2: Baseline | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Iris: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Cornea: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Anterior Segment: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Conjunctiva: Study Eye 1: Baseline | 1 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Lens: Study Eye 1: Baseline | 2 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Conjunctiva: Study Eye 1: Month 12 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Anterior Segment: Study Eye 1: Baseline | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Conjunctiva: Study Eye 2: Baseline | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Lens: Study Eye 1: Month 12 | 4 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Conjunctiva: Study Eye 2: Month 12 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Anterior Segment: Study Eye 2: Baseline | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Iris: Study Eye 1: Baseline | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Lens: Study Eye 2: Baseline | 2 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Clinically Significant Abnormalities in Slit Lamp Examination | Iris: Study Eye 1: Month 12 | 0 Participants |
Primary
Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading
The following lens opacity grades are reported for categories 1-4: Nuclear Opalescence grade, Nuclear Color grade, Cortical Cataract grade, and Posterior Cataract grade. Opacification severity is graded on a decimal scale, scores can range from 0.1 (no opacity) to 6.9 (maximum opacity) for the Nuclear Opalescence and Nuclear Color grades; and scores can range from 0.1 (lens clear) to 5.9 (lens unclear) for the Cortical and Posterior Cataract grades. Category 1 includes values 1, 1.0 and 0.x, Category 2 includes values 2, 2.0 and 1.x, Category 3 includes values 3, 3.0 and 2.x, and Category 4 includes values 4, 4.0, 3.x and any values above 4. For each opacification type the higher grading scores indicate greater severity.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified category of specified parameter.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 1: Study Eye 1 | 13 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 1: Study Eye 1 | 13 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 2: Study Eye 1 | 1 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 1: Study Eye 1 | 14 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 3: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 1: Study Eye 2 | 14 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 4: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 2: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 1: Study Eye 2 | 14 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 3: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 2: Study Eye 2 | 1 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 3: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 3: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 2: Study Eye 2 | 1 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 4: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 4: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 1: Study Eye 1 | 13 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 2: Study Eye 1 | 1 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 2: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 1: Study Eye 2 | 15 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 3: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 3: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 4: Study Eye 1 | 1 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 2: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 1: Study Eye 2 | 15 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 4: Study Eye 1 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 2: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 3: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 3: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 4: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 4: Study Eye 2 | 0 Participants |
| Treatment Period 1: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 4: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 4: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 1: Study Eye 1 | 38 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 2: Study Eye 1 | 8 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 3: Study Eye 1 | 4 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 4: Study Eye 1 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 1: Study Eye 2 | 38 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 2: Study Eye 2 | 10 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 3: Study Eye 2 | 2 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Opalescence Grade: Category 4: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 1: Study Eye 1 | 41 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 2: Study Eye 1 | 5 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 3: Study Eye 1 | 4 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 4: Study Eye 1 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 1: Study Eye 2 | 41 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 2: Study Eye 2 | 7 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 4: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 1: Study Eye 1 | 43 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 2: Study Eye 1 | 5 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 3: Study Eye 1 | 2 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 4: Study Eye 1 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 1: Study Eye 2 | 44 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 2: Study Eye 2 | 6 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 3: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Cortical Cataract Grade: Category 4: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 1: Study Eye 1 | 40 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 2: Study Eye 1 | 6 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 3: Study Eye 1 | 3 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 4: Study Eye 1 | 1 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 1: Study Eye 2 | 44 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 2: Study Eye 2 | 6 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Posterior Cataract Grade: Category 3: Study Eye 2 | 0 Participants |
| Treatment Period 2: BIIB111 | Ophthalmic Examination Assessment: Number of Participants With Lens Opacity Grading | Nuclear Color Grade: Category 3: Study Eye 2 | 2 Participants |
Primary
Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug/surgical procedure, whether or not related to the investigational product or with the surgical procedure. TEAEs are defined as AEs starting on or after the day of the first surgery.
Time frame: Day 0 (surgery) in period 1 up to last follow up visit in period 2 (approximately 2 years)
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. The AEs data were collected and reported for unique participants enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Period 1: BIIB111 | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | 100 percentage of participants |
| Treatment Period 2: BIIB111 | Percentage of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) | 96.4 percentage of participants |
Primary
SD-OCT: Central Ellipsoid Area at Month 12
SD-OCT was used to assess change in central ellipsoid area. The measurements were taken after dilation of the participant's pupil.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Central Ellipsoid Area at Month 12 | Study Eye 1 | 3.213 square millimeters (mm^2) | Standard Deviation 2.1098 |
| Treatment Period 1: BIIB111 | SD-OCT: Central Ellipsoid Area at Month 12 | Study Eye 2 | 4.404 square millimeters (mm^2) | Standard Deviation 2.2848 |
| Treatment Period 2: BIIB111 | SD-OCT: Central Ellipsoid Area at Month 12 | Study Eye 1 | 2.971 square millimeters (mm^2) | Standard Deviation 1.7374 |
| Treatment Period 2: BIIB111 | SD-OCT: Central Ellipsoid Area at Month 12 | Study Eye 2 | 3.810 square millimeters (mm^2) | Standard Deviation 2.5563 |
Primary
SD-OCT: Central Horizontal Ellipsoid Width at Month 12
SD-OCT was used to assess change in central horizontal ellipsoid width. The measurements were taken after dilation of the participant's pupil.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Central Horizontal Ellipsoid Width at Month 12 | Study Eye 1 | 2346.0 microns (μ) | Standard Deviation 1511.67 |
| Treatment Period 1: BIIB111 | SD-OCT: Central Horizontal Ellipsoid Width at Month 12 | Study Eye 2 | 2230.2 microns (μ) | Standard Deviation 1122.89 |
| Treatment Period 2: BIIB111 | SD-OCT: Central Horizontal Ellipsoid Width at Month 12 | Study Eye 1 | 1951.2 microns (μ) | Standard Deviation 1223.26 |
| Treatment Period 2: BIIB111 | SD-OCT: Central Horizontal Ellipsoid Width at Month 12 | Study Eye 2 | 1950.1 microns (μ) | Standard Deviation 1188.74 |
Primary
SD-OCT: Choroidal Thickness at Foveal Center at Month 12
SD-OCT was used to assess change in choroidal thickness. The measurements were taken after dilation of the participant's pupil.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Choroidal Thickness at Foveal Center at Month 12 | Study Eye 1 | 185.5 microns (μ) | Standard Deviation 81.72 |
| Treatment Period 1: BIIB111 | SD-OCT: Choroidal Thickness at Foveal Center at Month 12 | Study Eye 2 | 207.6 microns (μ) | Standard Deviation 85.89 |
| Treatment Period 2: BIIB111 | SD-OCT: Choroidal Thickness at Foveal Center at Month 12 | Study Eye 1 | 174.2 microns (μ) | Standard Deviation 85.33 |
| Treatment Period 2: BIIB111 | SD-OCT: Choroidal Thickness at Foveal Center at Month 12 | Study Eye 2 | 190.2 microns (μ) | Standard Deviation 87.4 |
Primary
SD-OCT: Square Root of Central Ellipsoid Area at Month 12
SD-OCT was used to assess change in square root of central ellipsoid area. The measurements were taken after dilation of the participant's pupil.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Square Root of Central Ellipsoid Area at Month 12 | Study Eye 1 | 1.6980 mm | Standard Deviation 0.62031 |
| Treatment Period 1: BIIB111 | SD-OCT: Square Root of Central Ellipsoid Area at Month 12 | Study Eye 2 | 2.0331 mm | Standard Deviation 0.55575 |
| Treatment Period 2: BIIB111 | SD-OCT: Square Root of Central Ellipsoid Area at Month 12 | Study Eye 1 | 1.6346 mm | Standard Deviation 0.55842 |
| Treatment Period 2: BIIB111 | SD-OCT: Square Root of Central Ellipsoid Area at Month 12 | Study Eye 2 | 1.8468 mm | Standard Deviation 0.64385 |
Primary
SD-OCT: Total Macular Volume at Month 12
SD-OCT was used to assess change in total macular volume. The measurements were taken after dilation of the participant's pupil.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Total Macular Volume at Month 12 | Study Eye 1 | 6.770 cubic millimeters (mm^3) | Standard Deviation 1.1384 |
| Treatment Period 1: BIIB111 | SD-OCT: Total Macular Volume at Month 12 | Study Eye 2 | 6.903 cubic millimeters (mm^3) | Standard Deviation 1.0875 |
| Treatment Period 2: BIIB111 | SD-OCT: Total Macular Volume at Month 12 | Study Eye 1 | 6.638 cubic millimeters (mm^3) | Standard Deviation 1.0934 |
| Treatment Period 2: BIIB111 | SD-OCT: Total Macular Volume at Month 12 | Study Eye 2 | 6.741 cubic millimeters (mm^3) | Standard Deviation 1.1616 |
Primary
Spectral Domain Optical Coherence Tomography (SD-OCT): Foveal Subfield Thickness at Month 12
SD-OCT was used to assess change in foveal subfield thickness. The measurements were taken after dilation of the participant's pupil.
Time frame: Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Spectral Domain Optical Coherence Tomography (SD-OCT): Foveal Subfield Thickness at Month 12 | Study Eye 1 | 290.7 microns (µ) | Standard Deviation 69.94 |
| Treatment Period 1: BIIB111 | Spectral Domain Optical Coherence Tomography (SD-OCT): Foveal Subfield Thickness at Month 12 | Study Eye 2 | 283.8 microns (µ) | Standard Deviation 46.65 |
| Treatment Period 2: BIIB111 | Spectral Domain Optical Coherence Tomography (SD-OCT): Foveal Subfield Thickness at Month 12 | Study Eye 1 | 258.0 microns (µ) | Standard Deviation 58.2 |
| Treatment Period 2: BIIB111 | Spectral Domain Optical Coherence Tomography (SD-OCT): Foveal Subfield Thickness at Month 12 | Study Eye 2 | 270.9 microns (µ) | Standard Deviation 51.66 |
Primary
Vital Signs: Change From Baseline in Blood Pressure at Month 12
Change from baseline in Systolic and diastolic blood pressures (BP) (millimeters of mercury \[mmHg\]) were reported.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Vital Signs: Change From Baseline in Blood Pressure at Month 12 | Systolic BP: Baseline | 122.3 mmHg | Standard Deviation 14.73 |
| Treatment Period 1: BIIB111 | Vital Signs: Change From Baseline in Blood Pressure at Month 12 | Systolic BP: Change at Month 12 | -7.2 mmHg | Standard Deviation 16.12 |
| Treatment Period 1: BIIB111 | Vital Signs: Change From Baseline in Blood Pressure at Month 12 | Diastolic BP: Baseline | 78.3 mmHg | Standard Deviation 9.56 |
| Treatment Period 1: BIIB111 | Vital Signs: Change From Baseline in Blood Pressure at Month 12 | Diastolic BP: Change at Month 12 | -1.0 mmHg | Standard Deviation 11.29 |
| Treatment Period 2: BIIB111 | Vital Signs: Change From Baseline in Blood Pressure at Month 12 | Diastolic BP: Change at Month 12 | -1.9 mmHg | Standard Deviation 9.6 |
| Treatment Period 2: BIIB111 | Vital Signs: Change From Baseline in Blood Pressure at Month 12 | Systolic BP: Baseline | 125.4 mmHg | Standard Deviation 11.52 |
| Treatment Period 2: BIIB111 | Vital Signs: Change From Baseline in Blood Pressure at Month 12 | Diastolic BP: Baseline | 80.5 mmHg | Standard Deviation 6.91 |
| Treatment Period 2: BIIB111 | Vital Signs: Change From Baseline in Blood Pressure at Month 12 | Systolic BP: Change at Month 12 | -2.0 mmHg | Standard Deviation 10.65 |
Primary
Vital Signs: Change From Baseline in Pulse Rate at Month 12
Change from baseline in pulse rate (beats per minute) were reported.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Vital Signs: Change From Baseline in Pulse Rate at Month 12 | Baseline | 69.8 beats per minute | Standard Deviation 13.31 |
| Treatment Period 1: BIIB111 | Vital Signs: Change From Baseline in Pulse Rate at Month 12 | Change at Month 12 | 6.7 beats per minute | Standard Deviation 16.41 |
| Treatment Period 2: BIIB111 | Vital Signs: Change From Baseline in Pulse Rate at Month 12 | Baseline | 71.5 beats per minute | Standard Deviation 10.91 |
| Treatment Period 2: BIIB111 | Vital Signs: Change From Baseline in Pulse Rate at Month 12 | Change at Month 12 | 0.9 beats per minute | Standard Deviation 10.46 |
Secondary
AF: Change From Baseline in Distance From Foveal Center to Nearest Border of Preserved AF at Month 12
Fundus Autofluoroscence was used to assess change in distance from foveal center to nearest border of preserved autofluoroscence. Here negative values indicate decline in total area of preserved autofluoroscence.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | AF: Change From Baseline in Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Change at Month 12: Study Eye 1 | -160.000 mm | Standard Deviation 197.9094 |
| Treatment Period 1: BIIB111 | AF: Change From Baseline in Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Change at Month 12: Study Eye 2 | -76.000 mm | Standard Deviation 71.9107 |
| Treatment Period 2: BIIB111 | AF: Change From Baseline in Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Change at Month 12: Study Eye 1 | -94.321 mm | Standard Deviation 106.4964 |
| Treatment Period 2: BIIB111 | AF: Change From Baseline in Distance From Foveal Center to Nearest Border of Preserved AF at Month 12 | Change at Month 12: Study Eye 2 | -80.596 mm | Standard Deviation 135.5793 |
Secondary
AF: Change From Baseline in Square Root of Total Area of Preserved AF at Month 12
Fundus AF was used to assess change in square root of total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper AF compared with the background areas of surrounding atrophy. Here negative values indicate decline in total area of preserved autofluoroscence.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | AF: Change From Baseline in Square Root of Total Area of Preserved AF at Month 12 | Change at Month 12: Study Eye 1 | -0.1981 mm | Standard Deviation 0.13033 |
| Treatment Period 1: BIIB111 | AF: Change From Baseline in Square Root of Total Area of Preserved AF at Month 12 | Change at Month 12: Study Eye 2 | -0.1345 mm | Standard Deviation 0.04362 |
| Treatment Period 2: BIIB111 | AF: Change From Baseline in Square Root of Total Area of Preserved AF at Month 12 | Change at Month 12: Study Eye 1 | -0.2197 mm | Standard Deviation 0.18111 |
| Treatment Period 2: BIIB111 | AF: Change From Baseline in Square Root of Total Area of Preserved AF at Month 12 | Change at Month 12: Study Eye 2 | -0.1736 mm | Standard Deviation 0.1609 |
Secondary
AF: Change From Baseline in Total Area of Preserved Autofluorescence at Month 12
Fundus AF was used to assess change in total area of preserved AF. Areas of preserved AF were identified as well-demarcated regions of relative hyper autofluorescence (hyper AF) compared with the background areas of surrounding atrophy. Here negative values indicate decline in total area of preserved autofluoroscence.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | AF: Change From Baseline in Total Area of Preserved Autofluorescence at Month 12 | Change at Month 12: Study Eye 1 | -1.158 mm^2 | Standard Deviation 1.3362 |
| Treatment Period 1: BIIB111 | AF: Change From Baseline in Total Area of Preserved Autofluorescence at Month 12 | Change at Month 12: Study Eye 2 | -0.772 mm^2 | Standard Deviation 0.5381 |
| Treatment Period 2: BIIB111 | AF: Change From Baseline in Total Area of Preserved Autofluorescence at Month 12 | Change at Month 12: Study Eye 1 | -1.502 mm^2 | Standard Deviation 1.9315 |
| Treatment Period 2: BIIB111 | AF: Change From Baseline in Total Area of Preserved Autofluorescence at Month 12 | Change at Month 12: Study Eye 2 | -1.313 mm^2 | Standard Deviation 1.9967 |
Secondary
Change From Baseline in BCVA as Measured by the ETDRS Chart
BCVA was assessed for both eyes using the ETDRS VA chart. BCVA test should be performed prior to pupil dilation, and distance refraction should be carried out before BCVA is measured. Initially, letters are read at a distance of 4 meters from the chart. If \<20 letters are read at 4 meters, testing at 1 meter should be performed. BCVA is reported as number of letters read correctly by the participant using the ETDRS Scale (ranging from 0 to 100 letters) in the study eyes. 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.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Change From Baseline in BCVA as Measured by the ETDRS Chart | Change at Month 12: Study Eye 1 | -8.6 letters | Standard Deviation 24.55 |
| Treatment Period 1: BIIB111 | Change From Baseline in BCVA as Measured by the ETDRS Chart | Change at Month 12: Study Eye 2 | 2.2 letters | Standard Deviation 2.93 |
| Treatment Period 2: BIIB111 | Change From Baseline in BCVA as Measured by the ETDRS Chart | Change at Month 12: Study Eye 1 | -1.3 letters | Standard Deviation 7.77 |
| Treatment Period 2: BIIB111 | Change From Baseline in BCVA as Measured by the ETDRS Chart | Change at Month 12: Study Eye 2 | -2.2 letters | Standard Deviation 8.27 |
Secondary
Microperimetry: Change From Baseline in Bivariate Contour Ellipse Area 63% at Month 12
Microperimetry was conducted to assess change in bivariate contour ellipse area 63%. A negative change from baseline indicates decline in bivariate contour ellipse area 63%.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Microperimetry: Change From Baseline in Bivariate Contour Ellipse Area 63% at Month 12 | Change at Month 12: Study Eye 1 | 4.42 deg^2 | Standard Deviation 14.383 |
| Treatment Period 1: BIIB111 | Microperimetry: Change From Baseline in Bivariate Contour Ellipse Area 63% at Month 12 | Change at Month 12: Study Eye 2 | -0.02 deg^2 | Standard Deviation 1.296 |
| Treatment Period 2: BIIB111 | Microperimetry: Change From Baseline in Bivariate Contour Ellipse Area 63% at Month 12 | Change at Month 12: Study Eye 1 | -0.22 deg^2 | Standard Deviation 6.733 |
| Treatment Period 2: BIIB111 | Microperimetry: Change From Baseline in Bivariate Contour Ellipse Area 63% at Month 12 | Change at Month 12: Study Eye 2 | 0.63 deg^2 | Standard Deviation 5.681 |
Secondary
Microperimetry: Change From Baseline in Fixation Losses (in Percentage) at Month 12
Microperimetry was conducted to assess change in fixation losses (in percentage) which samples the optic nerve blind spot for positive responses. A negative change from baseline indicates decline in fixation losses.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Microperimetry: Change From Baseline in Fixation Losses (in Percentage) at Month 12 | Change at Month 12: Study Eye 1 | 5.3 percentage | Standard Deviation 13.6 |
| Treatment Period 1: BIIB111 | Microperimetry: Change From Baseline in Fixation Losses (in Percentage) at Month 12 | Change at Month 12: Study Eye 2 | -6.3 percentage | Standard Deviation 12.5 |
| Treatment Period 2: BIIB111 | Microperimetry: Change From Baseline in Fixation Losses (in Percentage) at Month 12 | Change at Month 12: Study Eye 1 | -4.5 percentage | Standard Deviation 11.72 |
| Treatment Period 2: BIIB111 | Microperimetry: Change From Baseline in Fixation Losses (in Percentage) at Month 12 | Change at Month 12: Study Eye 2 | 2.8 percentage | Standard Deviation 7.4 |
Secondary
Microperimetry: Change From Baseline in Retinal Mean Sensitivity at Month 12
Microperimetry was conducted to assess change in retinal mean sensitivity within the macula. Retinal mean sensitivity to light was measured in decibels in multiple spots across the central and peripheral retina (entire visual field). Higher numbers (decibels) indicate higher retinal sensitivity. A negative change from baseline indicates decline in retinal sensitivity.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Microperimetry: Change From Baseline in Retinal Mean Sensitivity at Month 12 | Change at Month 12: Study Eye 1 | -0.79 dB | Standard Deviation 1.16 |
| Treatment Period 1: BIIB111 | Microperimetry: Change From Baseline in Retinal Mean Sensitivity at Month 12 | Change at Month 12: Study Eye 2 | 0.15 dB | Standard Deviation 0.725 |
| Treatment Period 2: BIIB111 | Microperimetry: Change From Baseline in Retinal Mean Sensitivity at Month 12 | Change at Month 12: Study Eye 1 | -0.38 dB | Standard Deviation 1.931 |
| Treatment Period 2: BIIB111 | Microperimetry: Change From Baseline in Retinal Mean Sensitivity at Month 12 | Change at Month 12: Study Eye 2 | -0.73 dB | Standard Deviation 1.435 |
Secondary
Microperimetry: Change From Baseline in the Bivariate Contour Ellipse Area 95% at Month 12
Microperimetry was conducted to assess change in bivariate contour ellipse area 95%. A negative change from baseline indicates decline in bivariate contour ellipse area 95%.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | Microperimetry: Change From Baseline in the Bivariate Contour Ellipse Area 95% at Month 12 | Change at Month 12: Study Eye 1 | 13.23 deg^2 | Standard Deviation 43.125 |
| Treatment Period 1: BIIB111 | Microperimetry: Change From Baseline in the Bivariate Contour Ellipse Area 95% at Month 12 | Change at Month 12: Study Eye 2 | -0.09 deg^2 | Standard Deviation 3.866 |
| Treatment Period 2: BIIB111 | Microperimetry: Change From Baseline in the Bivariate Contour Ellipse Area 95% at Month 12 | Change at Month 12: Study Eye 1 | -0.66 deg^2 | Standard Deviation 20.204 |
| Treatment Period 2: BIIB111 | Microperimetry: Change From Baseline in the Bivariate Contour Ellipse Area 95% at Month 12 | Change at Month 12: Study Eye 2 | 1.90 deg^2 | Standard Deviation 17.006 |
Secondary
SD-OCT: Change From Baseline in Central Ellipsoid Area at Month 12
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 decline in central ellipsoid area.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in Central Ellipsoid Area at Month 12 | Change at Month 12: Study Eye 1 | -0.408 mm^2 | Standard Deviation 0.2184 |
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in Central Ellipsoid Area at Month 12 | Change at Month 12: Study Eye 2 | -0.466 mm^2 | Standard Deviation 0.3543 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in Central Ellipsoid Area at Month 12 | Change at Month 12: Study Eye 1 | -0.452 mm^2 | Standard Deviation 0.2776 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in Central Ellipsoid Area at Month 12 | Change at Month 12: Study Eye 2 | -0.369 mm^2 | Standard Deviation 0.3425 |
Secondary
SD-OCT: Change From Baseline in Foveal Subfield Thickness at Month 12
SD-OCT was used to assess change in foveal subfield thickness. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in foveal subfield thickness.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in Foveal Subfield Thickness at Month 12 | Change at Month 12: Study Eye 1 | 1.7 microns (μ) | Standard Deviation 53.08 |
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in Foveal Subfield Thickness at Month 12 | Change at Month 12: Study Eye 2 | -3.5 microns (μ) | Standard Deviation 7.4 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in Foveal Subfield Thickness at Month 12 | Change at Month 12: Study Eye 1 | -2.9 microns (μ) | Standard Deviation 12.02 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in Foveal Subfield Thickness at Month 12 | Change at Month 12: Study Eye 2 | -5.7 microns (μ) | Standard Deviation 23.96 |
Secondary
SD-OCT: Change From Baseline in Square Root of Central Ellipsoid Area at Month 12
SD-OCT was used to assess change in square root of central ellipsoid area. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in square root of central ellipsoid area.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in Square Root of Central Ellipsoid Area at Month 12 | Change at Month 12: Study Eye 1 | -0.1348 mm | Standard Deviation 0.0811 |
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in Square Root of Central Ellipsoid Area at Month 12 | Change at Month 12: Study Eye 2 | -0.1121 mm | Standard Deviation 0.08193 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in Square Root of Central Ellipsoid Area at Month 12 | Change at Month 12: Study Eye 1 | -0.1345 mm | Standard Deviation 0.06117 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in Square Root of Central Ellipsoid Area at Month 12 | Change at Month 12: Study Eye 2 | -0.0944 mm | Standard Deviation 0.09347 |
Secondary
SD-OCT: Change From Baseline in the Central Horizontal Ellipsoid Width at Month 12
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 decline in central horizontal ellipsoid width.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in the Central Horizontal Ellipsoid Width at Month 12 | Change at Month 12: Study Eye 1 | -156.8 microns (μ) | Standard Deviation 185.66 |
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in the Central Horizontal Ellipsoid Width at Month 12 | Change at Month 12: Study Eye 2 | -217.5 microns (μ) | Standard Deviation 388.56 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in the Central Horizontal Ellipsoid Width at Month 12 | Change at Month 12: Study Eye 1 | -161.5 microns (μ) | Standard Deviation 299 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in the Central Horizontal Ellipsoid Width at Month 12 | Change at Month 12: Study Eye 2 | -150.4 microns (μ) | Standard Deviation 360.87 |
Secondary
SD-OCT: Change From Baseline in the Choroidal Thickness at Foveal Center at Month 12
SD-OCT was used to assess change in choroidal thickness. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in choroidal thickness.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in the Choroidal Thickness at Foveal Center at Month 12 | Change at Month 12: Study Eye 1 | -12.9 microns (μ) | Standard Deviation 35.57 |
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in the Choroidal Thickness at Foveal Center at Month 12 | Change at Month 12: Study Eye 2 | -9.8 microns (μ) | Standard Deviation 23.73 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in the Choroidal Thickness at Foveal Center at Month 12 | Change at Month 12: Study Eye 1 | -13.7 microns (μ) | Standard Deviation 30.73 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in the Choroidal Thickness at Foveal Center at Month 12 | Change at Month 12: Study Eye 2 | 2.9 microns (μ) | Standard Deviation 23.62 |
Secondary
SD-OCT: Change From Baseline in Total Macular Volume at Month 12
SD-OCT was used to assess change in total macular volume. The measurements were taken after dilation of the participant's pupil. A negative change from baseline indicates decline in total macular volume.
Time frame: Baseline, Month 12
Population: All Treated Subjects analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of specified eye.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in Total Macular Volume at Month 12 | Change at Month 12: Study Eye 1 | -0.201 mm^3 | Standard Deviation 0.2275 |
| Treatment Period 1: BIIB111 | SD-OCT: Change From Baseline in Total Macular Volume at Month 12 | Change at Month 12: Study Eye 2 | -0.093 mm^3 | Standard Deviation 0.1344 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in Total Macular Volume at Month 12 | Change at Month 12: Study Eye 1 | -0.188 mm^3 | Standard Deviation 0.14 |
| Treatment Period 2: BIIB111 | SD-OCT: Change From Baseline in Total Macular Volume at Month 12 | Change at Month 12: Study Eye 2 | -0.233 mm^3 | Standard Deviation 0.3969 |