Trial · NCT04435366
A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
NCT04435366, Phase 3, Completed, IVERIC bio, Inc.; results first posted 2023-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor). Trials, record NCT04435366. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04435366
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 3 Safety and Efficacy Study of Intravitreal Administration of Zimura (Complement C5 Inhibitor)
- NCT number
- NCT04435366
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 448 participants, actual
- Lead sponsor
- IVERIC bio, Inc.
- Conditions
- Geographic Atrophy, Macular Degeneration
- Interventions
- Avacincaptad Pegol, Sham
- First posted
- 2020-06-17
- Last updated
- 2025-10-21
- Results first posted
- 2023-12-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | 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. |
| 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 | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Baseline to month 12 | ITT analysis set | millimeters (mm)/year | LEAST_SQUARES_MEAN |
| 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 | Baseline to month 24 | 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. | mm^2/year | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months | Baseline and month 24 | ITT analysis set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months | Baseline and month 24 | ITT analysis set | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months | Baseline, months 6, 12, and 18 | ITT analysis set with available data was analyzed | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 24 Months | Baseline and month 24 | ITT analysis | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Categorical One-level Loss in VFQ-25 Subscale | Baseline up to month 24 | ITT analysis set with available data was analyzed | participants | NUMBER |
| SECONDARY | Time to Persistent Vision Loss | Baseline up to month 24 | ITT analysis set | months | MEDIAN |
Source ClinicalTrials.gov
Results by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Avacincaptad Pegol | 0.336 | Standard Error 0.032 | millimeters (mm)/year | |
| 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 | Sham | 0.392 | Standard Error 0.033 | millimeters (mm)/year | |
| 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 | Avacincaptad Pegol | 2.23 | Standard Error 0.124 | mm^2/year | |
| 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 | Avacincaptad Pegol and Sham | 2.10 | Standard Error 0.126 | mm^2/year | |
| 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 | Sham | 2.59 | Standard Error 0.085 | mm^2/year | |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months | Avacincaptad Pegol | -7.31 | Standard Error 1.07 | score on a scale | |
| Change From Baseline in Best Corrected Visual Acuity (BCVA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at 24 Months | Sham | -6.48 | Standard Error 1.05 | score on a scale | |
| Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months | Avacincaptad Pegol | -10.58 | Standard Error 1.20 | score on a scale | |
| Change From Baseline in Low Luminance (LL) BCVA Using ETDRS Letters at 24 Months | Sham | -9.1 | Standard Error 1.18 | score on a scale | |
| Change From Baseline in Visual Function Questionnaire (VFQ-25) Composite Scores at 6, 12 and 18 Months | Avacincaptad Pegol | Change at 6 months | -1.2 | Standard Deviation 10.56 | score on a scale |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Year 1 (12 Months) | STARTED | Avacincaptad Pegol | 225 | |
| Year 1 (12 Months) | STARTED | Avacincaptad Pegol and Sham | 0 | |
| Year 1 (12 Months) | STARTED | Sham | 223 | |
| Year 1 (12 Months) | Treated | Avacincaptad Pegol | 225 | |
| Year 1 (12 Months) | Treated | Avacincaptad Pegol and Sham | 0 | |
| Year 1 (12 Months) | Treated | Sham | 222 | |
| Year 1 (12 Months) | COMPLETED | Avacincaptad Pegol | 200 | |
| Year 1 (12 Months) | COMPLETED | Avacincaptad Pegol and Sham | 0 | |
| Year 1 (12 Months) | COMPLETED | Sham | 205 | |
| Year 1 (12 Months) | NOT COMPLETED | Avacincaptad Pegol | 25 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events640
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract | Eye disorders | Avacincaptad Pegol Only (up to 12 Months) | 6 | 225 | 8 |
| other | Cataract | Eye disorders | Avacincaptad Pegol Only (12 to 24 Months) | 7 | 96 | 8 |
| other | Cataract | Eye disorders | Avacincaptad Pegol and Sham Only (12 to 24 Months) | 4 | 93 | 5 |
| other | Cataract | Eye disorders | Sham Only (up to 12 Months) | 9 | 222 | 13 |
| other | Cataract | Eye disorders | Sham Only (12 to 24 Months) | 10 | 203 | 13 |
| other | Choroidal neovascularisation | Eye disorders | Avacincaptad Pegol Only (up to 12 Months) | 21 | 225 | 21 |
| other | Choroidal neovascularisation | Eye disorders | Avacincaptad Pegol Only (12 to 24 Months) | 11 | 96 | 13 |
| other | Choroidal neovascularisation | Eye disorders | Avacincaptad Pegol and Sham Only (12 to 24 Months) | 8 | 93 | 8 |
| other | Choroidal neovascularisation | Eye disorders | Sham Only (up to 12 Months) | 11 | 222 | 13 |
| other | Choroidal neovascularisation | Eye disorders | Sham Only (12 to 24 Months) | 19 | 203 | 21 |
1 to 10 of 640Source ClinicalTrials.gov
See all 640 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avacincaptad Pegol Only (up to 12 Months) | 4 | 225 |
| Total, all-cause mortality | Avacincaptad Pegol Only (12 to 24 Months) | 1 | 96 |
| Total, all-cause mortality | Avacincaptad Pegol and Sham Only (12 to 24 Months) | 4 | 93 |
| Total, all-cause mortality | Sham Only (up to 12 Months) | 1 | 222 |
| Total, all-cause mortality | Sham Only (12 to 24 Months) | 7 | 203 |
| Total, other adverse events | Avacincaptad Pegol Only (up to 12 Months) | 100 | 225 |
| Total, other adverse events | Avacincaptad Pegol Only (12 to 24 Months) | 51 | 96 |
| Total, other adverse events | Avacincaptad Pegol and Sham Only (12 to 24 Months) | 41 | 93 |
| Total, other adverse events | Sham Only (up to 12 Months) | 83 | 222 |
| Total, other adverse events | Sham Only (12 to 24 Months) | 77 | 203 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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The record and each of its lists are JSON, twenty rows a page. No key.
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