Zimura Compared to Sham in Patients With Autosomal Recessive Stargardt Disease (STGD1)

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IVERIC bio, Inc.

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