drugset / Trial / NCT03364153

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

NCT03364153 ↗

Phase 2 Completed 121 enrolled Astellas Pharma Global Development, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of avacincaptad pegol intravitreal injection compared to Sham in participants with autosomal recessive Stargardt disease 1 (STGD1).

Timeline

Start
2018-01-12
Primary completion
2025-03-31
Completion
2025-03-31

Outcome

Missed primary endpoint

registry analysis (superiority test); Avacincaptad Pegol vs Sham; p = 0.8669; difference in LS mean -0.0261 (95% CI -0.3334 to 0.2813); Mixed Models Analysis NCT03364153 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Avacincaptad Pegol Aptamer — Intravitreal

Indications