Trial · NCT02686658

Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration

NCT02686658, Phase 2, Phase 3, Completed, IVERIC bio, Inc.; results first posted 2023-05-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration. Trials, record NCT02686658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02686658

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Zimura in Participants With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
NCT number: NCT02686658
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 286 participants, actual
Lead sponsor: IVERIC bio, Inc.
Conditions: Geographic Atrophy, Dry Age-Related Macular Degeneration
Interventions: Avacincaptad Pegol, Sham
First posted: 2016-02-19
Last updated: 2025-06-10
Other registries' IDs: eudract:2015-003991-56
Results first posted: 2023-05-11

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence	Baseline and 12 months	The least squares mean change in geographic atrophy (GA) from baseline to Month 12 was measured by fundus autofluorescence (FAF). The square root of the GA area was used in the analysis. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for this primary endpoint; the Zimura 1 mg group was for descriptive purposes only.
Secondary	Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters	Baseline and 12 months	The least squares mean change in best-corrected visual acuity (BCVA) from baseline to Month 12 was measured using early treatment diabetic retinopathy study \[ETDRS\] letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.
Secondary	Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters	Baseline and 12 months	The least squares mean change in low luminance (LL) BCVA from baseline to Month 12 was measured using ETDRS letters. Per statistical analysis plan, only the Zimura 2 mg and 4 mg groups were evaluated for the secondary endpoints; the Zimura 1 mg group was for descriptive purposes only.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence	Baseline and 12 months	This study was conducted in 2 Parts. The analyses were based on comparisons of Zimura 2mg vs. Sham control and Zimura 4mg vs. Sham control. For comparison of Zimura 2mg vs. Sham control, participants randomized in Part 1 were combined with participants randomized in Part 2. Comparison of Zimura 4mg vs. Sham control was based on participants randomized in Part 2 only.	millimeters (mm)	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters	Baseline and 12 months	This study was conducted in 2 Parts. The analyses were based on comparisons of Zimura 2mg vs. Sham control and Zimura 4mg vs. Sham control. For comparison of Zimura 2mg vs. Sham control, participants randomized in Part 1 were combined with participants randomized in Part 2. Comparison of Zimura 4mg vs. Sham control was based on participants randomized in Part 2 only.	ETDRS Letters	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters	Baseline and 12 months	This study was conducted in 2 Parts. The analyses were based on comparisons of Zimura 2mg vs. Sham control and Zimura 4mg vs. Sham control. For comparison of Zimura 2mg vs. Sham control, participants randomized in Part 1 were combined with participants randomized in Part 2. Comparison of Zimura 4mg vs. Sham control was based on participants randomized in Part 2 only.	ETDRS Letters	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence	Zimura 2 mg [Part 1 & Part 2 Combined]	0.292	Standard Error 0.077	millimeters (mm)
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence	Sham [Part 1 & Part 2 Combined]	0.402	Standard Error 0.075	millimeters (mm)
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence	Zimura 4 mg [Part 2]	0.321	Standard Error 0.074	millimeters (mm)
Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence	Sham [Part 2]	0.444	Standard Error 0.072	millimeters (mm)
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters	Zimura 2 mg [Part 1 & Part 2 Combined]	-7.90	Standard Error 2.66	ETDRS Letters
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters	Sham [Part 1 & Part 2 Combined]	-9.29	Standard Error 2.59	ETDRS Letters
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters	Zimura 4 mg [Part 2]	-3.79	Standard Error 3.11	ETDRS Letters
Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters	Sham [Part 2]	-3.51	Standard Error 2.99	ETDRS Letters
Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters	Zimura 2 mg [Part 1 & Part 2 Combined]	-1.03	Standard Error 3.40	ETDRS Letters
Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters	Sham [Part 1 & Part 2 Combined]	-1.41	Standard Error 3.30	ETDRS Letters

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Zimura 1 mg [Part 1]	26
Overall Study	STARTED	Zimura 2 mg [Part 1]	25
Overall Study	STARTED	Sham [Part 1]	26
Overall Study	STARTED	Zimura 2 mg (Zimura 2mg+Sham) [Part 2]	42
Overall Study	STARTED	Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]	83
Overall Study	STARTED	Sham (Sham+Sham) [Part 2]	84
Overall Study	Month 12	Zimura 1 mg [Part 1]	23
Overall Study	Month 12	Zimura 2 mg [Part 1]	19
Overall Study	Month 12	Sham [Part 1]	19
Overall Study	Month 12	Zimura 2 mg (Zimura 2mg+Sham) [Part 2]	34

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events792

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
other	Conjunctival haemorrhage *	Eye disorders	Zimura 1 mg [Part 1]	2	26
other	Conjunctival haemorrhage *	Eye disorders	Zimura 2 mg [Part 1]	2	25
other	Conjunctival haemorrhage *	Eye disorders	Sham [Part 1]	1	26
other	Conjunctival haemorrhage *	Eye disorders	Zimura 2 mg (Zimura 2mg+Sham) [Part 2]	9	42
other	Conjunctival haemorrhage *	Eye disorders	Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]	28	83
other	Conjunctival haemorrhage *	Eye disorders	Sham (Sham+Sham) [Part 2]	12	84
other	Conjunctival haemorrhage *	Eye disorders	Zimura (Any Dose) [Part 1 & Part 2 Combined]	41	176
other	Conjunctival haemorrhage *	Eye disorders	Sham [Part 1 & Part 2 Combined]	13	110
other	Neovascular age-related macular degeneration*	Eye disorders	Zimura 1 mg [Part 1]	3	26
other	Neovascular age-related macular degeneration*	Eye disorders	Zimura 2 mg [Part 1]	2	25

1 to 10 of 792Source ClinicalTrials.gov

See all 792 adverse events

Adverse event totals24

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Zimura 1 mg [Part 1]	1	26
Total, all-cause mortality	Zimura 2 mg [Part 1]	0	25
Total, all-cause mortality	Sham [Part 1]	0	26
Total, all-cause mortality	Zimura 2 mg (Zimura 2mg+Sham) [Part 2]	1	42
Total, all-cause mortality	Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]	1	83
Total, all-cause mortality	Sham (Sham+Sham) [Part 2]	1	84
Total, all-cause mortality	Zimura (Any Dose) [Part 1 & Part 2 Combined]	3	176
Total, all-cause mortality	Sham [Part 1 & Part 2 Combined]	1	110
Total, other adverse events	Zimura 1 mg [Part 1]	13	26
Total, other adverse events	Zimura 2 mg [Part 1]	13	25

1 to 10 of 24Source ClinicalTrials.gov

See all 24 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32882310	RESULT	PubMed
37314061	DERIVED	PubMed
39538001	DERIVED	PubMed

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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