Zimura in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
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ClinicalTrials.gov Identifier: NCT02686658 |
Recruitment Status :
Completed
First Posted : February 19, 2016
Last Update Posted : March 21, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Geographic Atrophy Macular Degeneration | Drug: Zimura Other: Sham | Phase 2 Phase 3 |
Part 1: Approximately 66 subjects will be randomized in a 1:1:1 ratio to the following dose groups:
- Zimura Dose Administration 1
- Zimura Dose Administration 2
- Sham Administration 1
Part 2: Approximately 135 subjects will be randomized in a 1:2:2 ratio to the following dose groups:
- Zimura Dose Administration 3
- Zimura Dose Administration 4
- Sham Administration 2
Subjects will receive monthly intravitreal injections of Zimura or Sham for 18 months.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 286 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2/3 Randomized, Double-Masked, Controlled Trial to Assess the Safety and Efficacy of Intravitreous Administration of Zimura™ (Anti-C5 Aptamer) in Subjects With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration |
Actual Study Start Date : | January 2016 |
Actual Primary Completion Date : | September 26, 2019 |
Actual Study Completion Date : | April 23, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Dose Group 1
Zimura Dose Administration 1
|
Drug: Zimura
Zimura Dose Administration 1
Other Name: avacincaptad pegol |
Experimental: Dose Group 2
Zimura Dose Administration 2
|
Drug: Zimura
Zimura Dose Administration 2
Other Name: avaincaptad pegol |
Sham Comparator: Dose Group 3
Sham Administration 1
|
Other: Sham
Sham Administration 1 |
Experimental: Dose Group 4
Zimura Dose Administration 3
|
Drug: Zimura
Zimura Dose Administration 3
Other Name: avacincaptad pegol |
Experimental: Dose Group 5
Zimura Dose Administration 4
|
Drug: Zimura
Zimura Dose Administration 4
Other Name: avacincaptad pegol |
Sham Comparator: Dose Group 6
Sham Administration 2
|
Other: Sham
Sham Administration 2 |
- Change in geographic atrophy (GA) [ Time Frame: 12 months ]Mean rate of change in GA measured by fundus autofluorescence (FAF)
- Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]Mean change in BCVA (Early Treatment Diabetic Retinopathy Study [ETDRS] letter)

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects of either gender aged ≥ 50 years
- Diagnosis of Non-foveal GA secondary to dry AMD
Exclusion Criteria:
- Evidence of Choroidal Neovascularization (CNV)
- GA secondary to any condition other than AMD
- Any prior treatment for AMD 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 three (3) months of trial entry
- Any prior thermal laser in the macular region, regardless of indication
- Any ocular or periocular infection in the twelve (12) weeks
- Previous therapeutic radiation in the region of the study eye
- Any sign of diabetic retinopathy in either eye

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02686658

Responsible Party: | IVERIC bio, Inc. |
ClinicalTrials.gov Identifier: | NCT02686658 |
Other Study ID Numbers: |
OPH2003 |
First Posted: | February 19, 2016 Key Record Dates |
Last Update Posted: | March 21, 2022 |
Last Verified: | March 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Geographic Atrophy (GA) Dry age-related macular degeneration AMD Zimura |
Anti-inflammatory complement factor C5 inhibitor ARC1905 avacincaptad pegol |
Macular Degeneration Geographic Atrophy Atrophy Retinal Degeneration |
Retinal Diseases Eye Diseases Pathological Conditions, Anatomical |