Zimura in Participants 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
Results First Posted : May 11, 2023
Last Update Posted : May 11, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Geographic Atrophy Macular Degeneration | Drug: Zimura Other: Sham | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 286 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | The Reading Center team and Sponsor were also masked. |
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 20, 2016 |
Actual Primary Completion Date : | September 26, 2019 |
Actual Study Completion Date : | April 23, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Zimura 1 mg [Part 1]
Participants received 1 mg of Zimura in the study eye administered via IVT injection (50 µL) on Day 1 and monthly up to 18 months.
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Drug: Zimura
Zimura 20 mg/mL solution for intravitreal (IVT) injection
Other Name: avacincaptad pegol |
Experimental: Zimura 2 mg [Part 1]
Participants received 2 mg of Zimura in the study eye administered via IVT injection (100 µL) on Day 1 and monthly up to 18 months.
|
Drug: Zimura
Zimura 20 mg/mL solution for intravitreal (IVT) injection
Other Name: avacincaptad pegol |
Sham Comparator: Sham [Part 1]
Participants received a Sham injection of an empty, needleless syringe administered in the study eye on Day 1 and monthly up to 18 months.
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Other: Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection. |
Experimental: Zimura 2 mg (Zimura 2mg+Sham) [Part 2]
Participants received 2 mg of Zimura in the study eye administered via IVT injection (100 µL) and a subsequent Sham administration on Day 1 and monthly up to 18 months.
|
Drug: Zimura
Zimura 20 mg/mL solution for intravitreal (IVT) injection
Other Name: avacincaptad pegol Other: Sham The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection. |
Experimental: Zimura 4 mg (Zimura 2mg+Zimura 2mg) [Part 2]
Participants received 4 mg of Zimura in the study eye administered via two consecutive IVT injections (2 x 100 µL) on Day 1 and monthly up to 18 months.
|
Drug: Zimura
Zimura 20 mg/mL solution for intravitreal (IVT) injection
Other Name: avacincaptad pegol |
Sham Comparator: Sham (Sham+Sham) [Part 2]
Participants received two consecutive Sham injections of empty, needleless syringes administered in the study eye on Day 1 and monthly up to 18 months.
|
Other: Sham
The Sham procedure included the blunt opening of an empty, needleless syringe barrel placed on the conjunctiva in the inferotemporal quadrant of the eyeball to simulate the pressure of an injection. |
- Change From Baseline in Geographic Atrophy as Measured by Fundus Autofluorescence [ Time Frame: 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.
- Change From Baseline in Best Corrected Visual Acuity Using Early Treatment Diabetic Retinopathy Study Letters [ Time Frame: 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.
- Change From Baseline in Low Luminance BCVA Using Early Treatment Diabetic Retinopathy Study Letters [ Time Frame: 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.

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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:
- Participants 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

Documents provided by IVERIC bio, Inc.:
Responsible Party: | IVERIC bio, Inc. |
ClinicalTrials.gov Identifier: | NCT02686658 |
Other Study ID Numbers: |
OPH2003 2015-003991-56 ( EudraCT Number ) |
First Posted: | February 19, 2016 Key Record Dates |
Results First Posted: | May 11, 2023 |
Last Update Posted: | May 11, 2023 |
Last Verified: | April 2023 |
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 |