Macular Edema, Retinal Vein Occlusion
Conditions
Brief summary
This study will evaluate the safety and efficacy of a single intravitreal injection of AGN208397 to treat Macular Edema associated with Retinal Vein Occlusion. This study is being conducted in two stages: Stage 1 will enroll approximately 21 subjects who will receive a single open label intravitreal injection of either 75 ug, 300 ug, 600 ug or 900 ug of AGN208397 and be followed for 12 months post treatment; based on Stage 1 results, Stage 2 will enroll approximately 96 subjects who will receive a single masked intravitreal injection of one of three doses of AGN208397 or Ozurdex® and be followed for 12 months post treatment.
Interventions
DRUGAGN208397 intravitreal injection
AGN208397 intravitreal injection on Day 1.
DRUGdexamethasone intravitreal implant
Dexamethasone 700 ug intravitreal implant on Day 1.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* macular edema due to retinal vein occlusion * visual acuity in the study eye between 20/320 to 20/40
Exclusion criteria
* cataract surgery or Lasik within 3 months prior to study Day 1 or anticipated need for cataract surgery during study period (12 months) * use of injectable drugs in the study eye within 2 months prior to day 1 * active eye infection in either eye * visual acuity in the non-study eye of 20/200 or worse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 | Baseline, Month 1 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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. |
| Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 | Baseline, Month 1 | Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement. |
| Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 | Baseline, Month 1 | Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement. |
| Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 | Baseline, Month 1 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 | Baseline, Month 12 | Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement. |
| Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 | Baseline, Month 12 | Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement. |
| Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 | Baseline, Month 12 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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. |
| Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 | Baseline, Month 12 | BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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. |
Countries
Australia, Canada, Israel, South Africa, United States
Participant flow
Pre-assignment details
Doses for Stage 2 were selected based on the safety and pharmacodynamic results from Stage 1. No patients in Stage 1 were enrolled in Stage 2.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1 Cohort 4 AGN208397 intravitreal injection 900 ug on Day 1. | 6 |
| Stage 1 Cohort 3 AGN208397 intravitreal injection 600 ug on Day 1. | 6 |
| Stage 1 Cohort 2 AGN208397 intravitreal injection 300 ug on Day 1. | 6 |
| Stage 1 Cohort 1 AGN208397 intravitreal injection 75 ug on Day 1. | 3 |
| Stage 2 Arm 1 AGN208397 intravitreal injection 600 ug on Day 1. | 25 |
| Stage 2 Arm 2 AGN208397 intravitreal injection 450 ug on Day 1. | 26 |
| Stage 2 Arm 3 AGN208397 intravitreal injection 300 ug on Day 1. | 25 |
| Stage 2 Arm 4 Dexamethasone 700 ug intravitreal implant on Day 1. | 24 |
| Total | 121 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Personal Reasons | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Stage 1 Cohort 4 | Stage 1 Cohort 3 | Stage 1 Cohort 2 | Stage 1 Cohort 1 | Stage 2 Arm 1 | Stage 2 Arm 2 | Stage 2 Arm 3 | Stage 2 Arm 4 | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized <45 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 3 Participants | 10 Participants |
| Age, Customized >65 years | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 17 Participants | 13 Participants | 11 Participants | 12 Participants | 62 Participants |
| Age, Customized Between 45 and 65 years | 3 Participants | 4 Participants | 4 Participants | 0 Participants | 8 Participants | 10 Participants | 11 Participants | 9 Participants | 49 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 3 Participants | 1 Participants | 10 Participants | 11 Participants | 13 Participants | 12 Participants | 54 Participants |
| Sex: Female, Male Male | 4 Participants | 4 Participants | 3 Participants | 2 Participants | 15 Participants | 15 Participants | 12 Participants | 12 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 6 / 6 | 6 / 6 | 6 / 6 | 3 / 3 | 25 / 25 | 26 / 26 | 25 / 25 | 24 / 24 |
| serious Total, serious adverse events | 1 / 6 | 0 / 6 | 1 / 6 | 0 / 3 | 4 / 25 | 4 / 26 | 2 / 25 | 3 / 24 |
Outcome results
Primary
Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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: Baseline, Month 1
Population: Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Cohort 4 | Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 | Baseline | 49.5 Number of Letters Read Correctly | Standard Deviation 12.88 |
| Stage 1 Cohort 4 | Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 | Change from Baseline at Month 1 | 12.0 Number of Letters Read Correctly | Standard Deviation 9.38 |
| Stage 1 Cohort 3 | Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 | Change from Baseline at Month 1 | 12.5 Number of Letters Read Correctly | Standard Deviation 12.74 |
| Stage 1 Cohort 3 | Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 | Baseline | 47.6 Number of Letters Read Correctly | Standard Deviation 13.6 |
| Stage 1 Cohort 2 | Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 | Baseline | 58.2 Number of Letters Read Correctly | Standard Deviation 12.89 |
| Stage 1 Cohort 2 | Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 | Change from Baseline at Month 1 | 14.0 Number of Letters Read Correctly | Standard Deviation 12.35 |
| Stage 1 Cohort 1 | Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 | Baseline | 50.5 Number of Letters Read Correctly | Standard Deviation 14.27 |
| Stage 1 Cohort 1 | Change From Baseline at Month 1 in BCVA in the Study Eye During Stage 2 | Change from Baseline at Month 1 | 11.0 Number of Letters Read Correctly | Standard Deviation 11.99 |
Primary
Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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: Baseline, Month 1
Population: Safety Population: all patients who received study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Cohort 4 | Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 | Baseline | 54.5 Number of Letters Read Correctly | Standard Deviation 16.13 |
| Stage 1 Cohort 4 | Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 | Change from Baseline at Month 1 | 10.0 Number of Letters Read Correctly | Standard Deviation 8.72 |
| Stage 1 Cohort 3 | Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 | Change from Baseline at Month 1 | 11.7 Number of Letters Read Correctly | Standard Deviation 7.17 |
| Stage 1 Cohort 3 | Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 | Baseline | 50.2 Number of Letters Read Correctly | Standard Deviation 14.12 |
| Stage 1 Cohort 2 | Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 | Baseline | 59.7 Number of Letters Read Correctly | Standard Deviation 6.62 |
| Stage 1 Cohort 2 | Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 | Change from Baseline at Month 1 | 8.7 Number of Letters Read Correctly | Standard Deviation 4.84 |
| Stage 1 Cohort 1 | Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 | Baseline | 53.0 Number of Letters Read Correctly | Standard Deviation 9.54 |
| Stage 1 Cohort 1 | Change From Baseline at Month 1 in Best Corrected Visual Acuity (BCVA) in the Study Eye During Stage 1 | Change from Baseline at Month 1 | 9.7 Number of Letters Read Correctly | Standard Deviation 2.31 |
Primary
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Time frame: Baseline, Month 1
Population: Safety Population: all patients who received study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Cohort 4 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 | Baseline | 500.2 Microns | Standard Deviation 197.58 |
| Stage 1 Cohort 4 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 | Change from Baseline at Month 1 | -234.3 Microns | Standard Deviation 200.23 |
| Stage 1 Cohort 3 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 | Change from Baseline at Month 1 | -210.5 Microns | Standard Deviation 173.69 |
| Stage 1 Cohort 3 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 | Baseline | 495.8 Microns | Standard Deviation 163.13 |
| Stage 1 Cohort 2 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 | Baseline | 499.5 Microns | Standard Deviation 158.33 |
| Stage 1 Cohort 2 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 | Change from Baseline at Month 1 | -256.2 Microns | Standard Deviation 102.61 |
| Stage 1 Cohort 1 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 | Baseline | 468.3 Microns | Standard Deviation 24.34 |
| Stage 1 Cohort 1 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 1 | Change from Baseline at Month 1 | -206.7 Microns | Standard Deviation 96.4 |
Primary
Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Time frame: Baseline, Month 1
Population: Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Cohort 4 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 | Baseline | 612.6 Microns | Standard Deviation 166.15 |
| Stage 1 Cohort 4 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 | Change from Baseline at Month 1 | -298.5 Microns | Standard Deviation 174.59 |
| Stage 1 Cohort 3 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 | Change from Baseline at Month 1 | -314.1 Microns | Standard Deviation 169.35 |
| Stage 1 Cohort 3 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 | Baseline | 637.8 Microns | Standard Deviation 203.69 |
| Stage 1 Cohort 2 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 | Baseline | 597.9 Microns | Standard Deviation 217.54 |
| Stage 1 Cohort 2 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 | Change from Baseline at Month 1 | -307.0 Microns | Standard Deviation 217.98 |
| Stage 1 Cohort 1 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 | Baseline | 679.7 Microns | Standard Deviation 237.2 |
| Stage 1 Cohort 1 | Change From Baseline at Month 1 in Retinal Thickness in the Study Eye During Stage 2 | Change from Baseline at Month 1 | -317.3 Microns | Standard Deviation 212.51 |
Secondary
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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: Baseline, Month 12
Population: Safety Population: all patients who received study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Cohort 4 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 | Baseline | 54.5 Number of Letters Read Correctly | Standard Deviation 16.13 |
| Stage 1 Cohort 4 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 | Change from Baseline at Month 12 (N=6, 5, 6, 3) | 14.2 Number of Letters Read Correctly | Standard Deviation 15.3 |
| Stage 1 Cohort 3 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 | Change from Baseline at Month 12 (N=6, 5, 6, 3) | 0.8 Number of Letters Read Correctly | Standard Deviation 24.88 |
| Stage 1 Cohort 3 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 | Baseline | 50.2 Number of Letters Read Correctly | Standard Deviation 14.12 |
| Stage 1 Cohort 2 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 | Baseline | 59.7 Number of Letters Read Correctly | Standard Deviation 6.62 |
| Stage 1 Cohort 2 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 | Change from Baseline at Month 12 (N=6, 5, 6, 3) | 11.0 Number of Letters Read Correctly | Standard Deviation 7.43 |
| Stage 1 Cohort 1 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 | Baseline | 53.0 Number of Letters Read Correctly | Standard Deviation 9.54 |
| Stage 1 Cohort 1 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 1 | Change from Baseline at Month 12 (N=6, 5, 6, 3) | 14.0 Number of Letters Read Correctly | Standard Deviation 5.29 |
Secondary
Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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: Baseline, Month 12
Population: Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Cohort 4 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 | Baseline | 49.5 Number of Letters Read Correctly | Standard Deviation 12.88 |
| Stage 1 Cohort 4 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 | Change from Baseline at Month 12 | 8.0 Number of Letters Read Correctly | Standard Deviation 13.55 |
| Stage 1 Cohort 3 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 | Change from Baseline at Month 12 | 10.2 Number of Letters Read Correctly | Standard Deviation 17.22 |
| Stage 1 Cohort 3 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 | Baseline | 47.6 Number of Letters Read Correctly | Standard Deviation 13.6 |
| Stage 1 Cohort 2 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 | Baseline | 58.2 Number of Letters Read Correctly | Standard Deviation 12.89 |
| Stage 1 Cohort 2 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 | Change from Baseline at Month 12 | 12.4 Number of Letters Read Correctly | Standard Deviation 14.31 |
| Stage 1 Cohort 1 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 | Baseline | 50.5 Number of Letters Read Correctly | Standard Deviation 14.27 |
| Stage 1 Cohort 1 | Change From Baseline at Month 12 in BCVA in the Study Eye During Stage 2 | Change from Baseline at Month 12 | 5.0 Number of Letters Read Correctly | Standard Deviation 11.18 |
Secondary
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Time frame: Baseline, Month 12
Population: Safety Population: all patients who received study treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Cohort 4 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 | Baseline | 500.2 Microns | Standard Deviation 197.58 |
| Stage 1 Cohort 4 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 | Change from Baseline at Month 12 (N=3, 3, 3, 3) | -221.7 Microns | Standard Deviation 208.33 |
| Stage 1 Cohort 3 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 | Change from Baseline at Month 12 (N=3, 3, 3, 3) | -173.0 Microns | Standard Deviation 145.01 |
| Stage 1 Cohort 3 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 | Baseline | 495.8 Microns | Standard Deviation 163.13 |
| Stage 1 Cohort 2 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 | Baseline | 499.5 Microns | Standard Deviation 158.33 |
| Stage 1 Cohort 2 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 | Change from Baseline at Month 12 (N=3, 3, 3, 3) | -239.7 Microns | Standard Deviation 121.33 |
| Stage 1 Cohort 1 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 | Baseline | 468.3 Microns | Standard Deviation 24.34 |
| Stage 1 Cohort 1 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 1 | Change from Baseline at Month 12 (N=3, 3, 3, 3) | -167.7 Microns | Standard Deviation 96.72 |
Secondary
Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2
Retinal thickness is assessed by OCT in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement.
Time frame: Baseline, Month 12
Population: Per Protocol Population: all randomized and treated qualified patients with baseline and at least one post-baseline data for retinal thickness or BCVA in the study eye
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 1 Cohort 4 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 | Baseline | 612.6 Microns | Standard Deviation 166.15 |
| Stage 1 Cohort 4 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 | Change from Baseline at Month 12 | -252.8 Microns | Standard Deviation 177.09 |
| Stage 1 Cohort 3 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 | Change from Baseline at Month 12 | -218.0 Microns | Standard Deviation 166.57 |
| Stage 1 Cohort 3 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 | Baseline | 637.8 Microns | Standard Deviation 203.69 |
| Stage 1 Cohort 2 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 | Baseline | 597.9 Microns | Standard Deviation 217.54 |
| Stage 1 Cohort 2 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 | Change from Baseline at Month 12 | -208.2 Microns | Standard Deviation 200.48 |
| Stage 1 Cohort 1 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 | Baseline | 679.7 Microns | Standard Deviation 237.2 |
| Stage 1 Cohort 1 | Change From Baseline at Month 12 in Retinal Thickness in the Study Eye During Stage 2 | Change from Baseline at Month 12 | -169.1 Microns | Standard Deviation 213.5 |