Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)
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
| Sponsors |
Lead Sponsor: IVERIC bio, Inc. |
|---|---|
| Source | IVERIC bio, Inc. |
| Brief Summary | To evaluate the safety and efficacy of Zimura™ (complement factor C5 inhibitor) compared to Sham in subjects with autosomal recessive Stargardt disease 1 (STGD1). |
| Overall Status | Recruiting | ||||
|---|---|---|---|---|---|
| Start Date | 2018-01-12 | ||||
| Completion Date | 2024-09-01 | ||||
| Primary Completion Date | 2024-09-01 | ||||
| Phase | Phase 2 | ||||
| Study Type | Interventional | ||||
| Primary Outcome |
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| Enrollment | 120 |
| Condition | |
|---|---|
| Intervention |
Intervention Type: Drug Intervention Name: Zimura Description: Zimura Intravitreal Injection Arm Group Label: Cohort 1 Other Name: avacincaptad pegol Intervention Type: Other Intervention Name: Sham Description: Sham Intravitreal Injection Arm Group Label: Cohort 2 |
| Eligibility |
Criteria:
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 Gender: All Minimum Age: 18 Years Maximum Age: 60 Years Healthy Volunteers: No |
| Overall Contact |
Last Name: Sonia Cruz Phone: 347-322-8722 Email: [email protected] |
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| Location |
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| Location Countries |
Canada France Germany Hungary Israel Italy Spain United Kingdom United States |
|---|---|
| Verification Date |
2022-09-01 |
| Responsible Party |
Type: Sponsor |
| Keywords | |
| Has Expanded Access | No |
| Condition Browse | |
| Number Of Arms | 2 |
| Arm Group |
Label: Cohort 1 Type: Experimental Description: Zimura dose group Label: Cohort 2 Type: Sham Comparator Description: Sham dose group |
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Triple (Participant, Investigator, Outcomes Assessor) |
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