Geographic Atrophy, Macular Degeneration
Conditions
Keywords
Geographic Atrophy (GA), Age-related Macular Degeneration, AMD, Complement C5 inhibitor, avacincaptad pegol, IZERVAY
Brief summary
The objectives of this study was to evaluate the safety and efficacy of avacincaptad pegol intravitreal administration in participants with geographic atrophy secondary to age-related macular degeneration (AMD)
Detailed description
Participants were randomized in a 1:1 ratio to the following monthly treatment groups: * Avacincaptad pegol 2 mg * Sham At Month 12, the participants in the avacincaptad pegol 2mg treatment group were re-randomized to receive the study drug either on a monthly basis or on an every other month basis The participants initially randomized to sham treatment continued with monthly sham administration through Month 23 All participants had a final follow up visit at Month 24
Interventions
Avacincaptad Pegol Intravitreal Injection
DRUGSham
Sham Administration (includes placement of the blunt opening of an empty, needleless syringe barrel on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection)
Sponsors
IVERIC bio, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participant, Evaluating Investigator, Reading Center Personnel, and Sponsor Personnel are masked
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects of either gender aged ≥ 50 years * Diagnosis of Non-foveal GA secondary to dry AMD
Exclusion criteria
* Any prior treatment for AMD (dry or wet) or any prior intravitreal treatment for any indication in either eye, except oral supplements of vitamins and minerals * Any intraocular surgery or thermal laser within 3 months of trial entry. * Any prior thermal laser in the macular region, regardless of indication * Any ocular or periocular infection (including blepharitis), or ocular surface inflammation in the past 12 weeks. * Previous therapeutic radiation in the region of the study eye * Any sign of diabetic retinopathy in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12 | Baseline to month 12 | GA was associated with age-related macular degeneration (AMD) and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least squares mean used to determine mean rate of change in GA growth (slope) was measured by FAF. LS mean & SE were based on square-root transformation. |
| The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24 | Baseline to month 24 | GA was associated with AMD and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least square mean rate of GA growth (slope) was measured by FAF. LS mean & SE were based on untransformed data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months | Baseline, months 6, 12, and 18 | The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales. |
| Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months | Baseline and month 24 | The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales. |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months | Baseline and month 24 | BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS Visual Acuity Score (VAS) is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. |
| Time to Persistent Vision Loss | Baseline up to month 24 | Vision loss event was defined as a loss of ≥ 15 letters (equivalent to a loss of 3 lines on the ETDRS chart) in BCVA from Baseline measured at any two or more consecutive visits up to Month 24. These parameters were chosen as a 3-line BCVA loss (equivalent to doubling of visual angle) is widely recognized as a significant deterioration in vision and a minimum of two consecutive visits was representative of persistent disease progression. BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS was defined as the number of letters read on the ETDRS chart. Min and max possible scores are 0-100. A higher score represents better visual functioning. Kaplan-Meier method was used for analysis. Participants with an event were reported and not the median time to event. |
| Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Baseline up to month 24 | The National Eye Institute VFQ-25 measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively.Categorical one-level loss in each item was defined as decline of one or more levels at Month 24 on the original scale from Baseline (equivalently 20 points for general vision and 25 points for other vision items in a 0 to 100 scale). |
| Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months | Baseline and month 24 | BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. LL BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants ≥ 50 years of age diagnosed with geographic atrophy (GA) that was at least partly within 1.5 mm radius from the foveal center were enrolled in the study.
Pre-assignment details
Participants who met all inclusion criteria and none of the exclusion criteria were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Avacincaptad Pegol Participants received ACP 2 mg/eye via IVT injections monthly through Month 11 (Year 1). At month 12, participants were re-randomized to receive ACP 2 mg/eye via IVT injections monthly or ACP 2 mg/eye via IVT injections EOM at months 13, 15, 17, 19, 21, and 23 and sham injections at months 12, 14, 16,18, 20, and 22 (Year 2). Participants were followed up until month 24. | 225 |
| Sham Participants received sham injections; through Month 11 (Year 1). At month 12, participants continued to receive monthly sham injection from month 12 through month 23 (Year 2). Participants were followed up until month 24. | 222 |
| Total | 447 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Year 1 (12 Months) | Adverse Event | 3 | 0 | 2 |
| Year 1 (12 Months) | Death | 2 | 0 | 1 |
| Year 1 (12 Months) | Lost to Follow-up | 2 | 0 | 1 |
| Year 1 (12 Months) | Not treated | 0 | 0 | 1 |
| Year 1 (12 Months) | Patient non-compliance | 1 | 0 | 0 |
| Year 1 (12 Months) | Withdrawal by Subject | 17 | 0 | 13 |
| Year 2 (12 Months) | Adverse Event | 2 | 1 | 6 |
| Year 2 (12 Months) | Death | 1 | 4 | 6 |
| Year 2 (12 Months) | Lost to Follow-up | 0 | 2 | 0 |
| Year 2 (12 Months) | Withdrawal by Subject | 4 | 3 | 7 |
Baseline characteristics
| Characteristic | Sham | Total | Avacincaptad Pegol |
|---|---|---|---|
| Age, Continuous | 76.7 Years STANDARD_DEVIATION 8.8 | 76.5 Years STANDARD_DEVIATION 8.7 | 76.3 Years STANDARD_DEVIATION 8.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 23 Participants | 50 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 178 Participants | 346 Participants | 168 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 21 Participants | 51 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 34 Participants | 75 Participants | 41 Participants |
| Race (NIH/OMB) White | 186 Participants | 368 Participants | 182 Participants |
| Sex: Female, Male Female | 156 Participants | 310 Participants | 154 Participants |
| Sex: Female, Male Male | 66 Participants | 137 Participants | 71 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 4 / 225 | 1 / 96 | 4 / 93 | 1 / 222 | 7 / 203 |
| other Total, other adverse events | 100 / 225 | 51 / 96 | 41 / 93 | 83 / 222 | 77 / 203 |
| serious Total, serious adverse events | 31 / 225 | 18 / 96 | 16 / 93 | 36 / 222 | 25 / 203 |
Outcome results
Primary
The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12
GA was associated with age-related macular degeneration (AMD) and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least squares mean used to determine mean rate of change in GA growth (slope) was measured by FAF. LS mean & SE were based on square-root transformation.
Time frame: Baseline to month 12
Population: ITT analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Avacincaptad Pegol | The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12 | 0.336 millimeters (mm)/year | Standard Error 0.032 |
| Sham | The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by Autofluorescence (FAF) at 3 Time Points: Baseline, Month 6, and Month 12 | 0.392 millimeters (mm)/year | Standard Error 0.033 |
Comparison: Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol). Mixed Model for repeated measures (MMRM) was used to compare the treatment groups.p-value: 0.006495% CI: [0.016, 0.096]MMRM
Primary
The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24
GA was associated with AMD and caused bilateral, progressive, and irreversible loss of retinal tissue (photoreceptors, retinal pigment epithelium, and choriocapillaris) leading to a permanent loss of visual function and blindness. The least square mean rate of GA growth (slope) was measured by FAF. LS mean & SE were based on untransformed data.
Time frame: Baseline to month 24
Population: Re-rand analysis set-The subset of the ITT analysis set who were re-randomized at Month 12 and who were on sham and completed the Month 12 visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Avacincaptad Pegol | The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24 | 2.23 mm^2/year | Standard Error 0.124 |
| Sham | The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24 | 2.10 mm^2/year | Standard Error 0.126 |
| Sham | The Mean Rate of Growth (Slope) Estimated Based on GA Area Measured by FAF at 5 Timepoints: Baseline, Month 6, Month 12, Month 18, and Month 24 | 2.59 mm^2/year | Standard Error 0.085 |
Comparison: Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).p-value: 0.016595% CI: [0.066, 0.657]MMRM
Comparison: Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol and sham).p-value: 0.001595% CI: [0.189, 0.788]MMRM
Secondary
Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months
BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS Visual Acuity Score (VAS) is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.
Time frame: Baseline and month 24
Population: ITT analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Avacincaptad Pegol | Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months | -7.31 score on a scale | Standard Error 1.07 |
| Sham | Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months | -6.48 score on a scale | Standard Error 1.05 |
Comparison: Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).p-value: 0.5895% CI: [-3.79, 2.12]MMRM
Secondary
Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months
BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS is defined as the number of letters read on the ETDRS chart. Minimum and maximum possible scores are 0-100. A higher score represented better visual functioning. A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening. LL BCVA was measured by placing a 2.0 log unit neutral density filter over the best correction for that eye and having the participant read the normally illuminated ETDRS chart.
Time frame: Baseline and month 24
Population: ITT analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Avacincaptad Pegol | Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months | -10.58 score on a scale | Standard Error 1.2 |
| Sham | Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months | -9.1 score on a scale | Standard Error 1.18 |
Comparison: Difference in least squares mean between groups calculated as (sham) minus (avacincaptad pegol).p-value: 0.3895% CI: [-4.79, 1.81]MMRM
Secondary
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months
The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales.
Time frame: Baseline and month 24
Population: ITT analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Avacincaptad Pegol | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months | -7.735 score on a scale | Standard Error 0.95 |
| Sham | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months | -7.023 score on a scale | Standard Error 0.931 |
p-value: 0.592995% CI: [-3.326, 1.903]MMRM
Secondary
Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months
The National Eye Institute Visual Function Questionnaire-25 (VFQ-25) measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively. Each subscale score had a range of 0 to 100 inclusive and were calculated from the re-scaled raw data. A composite score was derived based on the average of the 11 vision-related subscales.
Time frame: Baseline, months 6, 12, and 18
Population: ITT analysis set with available data was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Avacincaptad Pegol | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months | Change at 6 months | -1.2 score on a scale | Standard Deviation 10.56 |
| Avacincaptad Pegol | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months | Change at 12 months | -3.4 score on a scale | Standard Deviation 11.05 |
| Avacincaptad Pegol | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months | Change at 18 months | -5.4 score on a scale | Standard Deviation 12.8 |
| Sham | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months | Change at 6 months | -1.6 score on a scale | Standard Deviation 9.98 |
| Sham | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months | Change at 12 months | -3.6 score on a scale | Standard Deviation 11.01 |
| Sham | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months | Change at 18 months | -4.7 score on a scale | Standard Deviation 11.53 |
Secondary
Number of Participants With Categorical One-level Loss in VFQ-25 Subscale
The National Eye Institute VFQ-25 measured the influence of visual disability and visual symptoms on general health domains. The VFQ-25 consisted of a base set of 25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. A higher score represented better visual functioning. Each item was then converted to a 0 to 100 scale so that the lowest and highest possible scores were set at 0 and 100 points, respectively.Categorical one-level loss in each item was defined as decline of one or more levels at Month 24 on the original scale from Baseline (equivalently 20 points for general vision and 25 points for other vision items in a 0 to 100 scale).
Time frame: Baseline up to month 24
Population: ITT analysis set with available data was analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Color Vision | 45 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Distance Vision | 56 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Near Vision | 61 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Peripheral Vision | 58 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | General Vision | 58 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Dependency | 55 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Driving | 27 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | General Health | 45 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Mental Health | 35 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Ocular Pain | 27 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Role Difficulties | 60 participants |
| Avacincaptad Pegol | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Social Function | 52 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Role Difficulties | 59 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Color Vision | 35 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Driving | 26 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Distance Vision | 43 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Ocular Pain | 20 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Near Vision | 49 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | General Health | 67 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Peripheral Vision | 65 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Social Function | 52 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | General Vision | 58 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Mental Health | 42 participants |
| Sham | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Dependency | 55 participants |
Secondary
Time to Persistent Vision Loss
Vision loss event was defined as a loss of ≥ 15 letters (equivalent to a loss of 3 lines on the ETDRS chart) in BCVA from Baseline measured at any two or more consecutive visits up to Month 24. These parameters were chosen as a 3-line BCVA loss (equivalent to doubling of visual angle) is widely recognized as a significant deterioration in vision and a minimum of two consecutive visits was representative of persistent disease progression. BCVA was assessed using ETDRS visual acuity testing charts. The ETDRS VAS was defined as the number of letters read on the ETDRS chart. Min and max possible scores are 0-100. A higher score represents better visual functioning. Kaplan-Meier method was used for analysis. Participants with an event were reported and not the median time to event.
Time frame: Baseline up to month 24
Population: ITT analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Avacincaptad Pegol | Time to Persistent Vision Loss | 17.02 months |
| Sham | Time to Persistent Vision Loss | 13.93 months |
p-value: 0.642495% CI: [0.57, 1.42]Log Rank