Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)
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ClinicalTrials.gov Identifier: NCT03364153 |
Recruitment Status :
Recruiting
First Posted : December 6, 2017
Last Update Posted : September 9, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stargardt Disease 1 | Drug: Zimura Other: Sham | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 2b Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Zimura™ (Complement C5 Inhibitor) Compared to Sham in Subjects With Autosomal Recessive Stargardt Disease |
Actual Study Start Date : | January 12, 2018 |
Estimated Primary Completion Date : | September 2024 |
Estimated Study Completion Date : | September 2024 |

Arm | Intervention/treatment |
---|---|
Experimental: Cohort 1
Zimura dose group
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Drug: Zimura
Zimura Intravitreal Injection
Other Name: avacincaptad pegol |
Sham Comparator: Cohort 2
Sham dose group
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Other: Sham
Sham Intravitreal Injection |
- Spectral Domain-Optical Coherence Tomography (SD-OCT) [ Time Frame: 18 months ]Mean rate of change in the area of ellipsoid zone defect measured by en face SD-OCT

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least two pathogenic mutations of ABCA4 gene confirmed by a CLIA-certified laboratory
- Best corrected visual acuity in the study eye between 20/20 - 20/200 Snellen equivalent, inclusive
Exclusion Criteria:
- Macular atrophy secondary to any condition other than STGD1 in either eye
- Any prior treatment for STGD1 including gene therapy, stem cell therapy or any prior intravitreal treatment for any indication in either eye
- Participation in an interventional study of a vitamin A derivative ≤ 3 months prior to screening
- Presence of intraocular inflammation, macular hole, pathologic myopia, epiretinal membrane, evidence of significant vitreo-macular traction, vitreous hemorrhage or aphakia
- Any intraocular surgery or thermal laser within 3 months of trial entry. Any prior thermal laser in the macular region
- Diabetes mellitus
- HbA1c value of ≥6.5%
- Stroke within 12 months of trial entry
- Any major surgical procedure within one month of trial entry or anticipated during the trial
- Any treatment with an investigational agent in the past 60 days for any condition
- Women who are pregnant or nursing
- Known serious allergies to the fluorescein dye used in angiography, povidone iodine, or to the components of the Zimura formulation

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): NCT03364153
Contact: Sonia Cruz | 347-322-8722 | sonia.cruz@ivericbio.com |

Responsible Party: | IVERIC bio, Inc. |
ClinicalTrials.gov Identifier: | NCT03364153 |
Other Study ID Numbers: |
OPH2005 |
First Posted: | December 6, 2017 Key Record Dates |
Last Update Posted: | September 9, 2022 |
Last Verified: | September 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Zimura ARC1905 complement factor C5 inhibitor avacincaptad pegol STGD1 |
Stargardt Disease Macular Degeneration Eye Diseases, Hereditary Eye Diseases |
Retinal Degeneration Retinal Diseases Genetic Diseases, Inborn |