Clinical Trial: A Phase 2/3 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
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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 Geogr
Brief Summary: The objectives of this study are to evaluate the safety and efficacy of intravitreous administration of Zimura® when administered in subjects with geographic atrophy (GA) secondary to dry age-related macular degeneration (AMD).
Detailed Summary:
Approximately 300 subjects will be randomized in a 1:1:1 ratio to the following dose groups:
- Zimura® Dose 1
- Zimura® Dose 2
- Sham
Subjects will receive monthly intravitreal injections of Zimura® or Sham for 24 months. An interim analysis will be conducted, following which, the study may be expanded to include more subjects.
Sponsor: Ophthotech Corporation
Current Primary Outcome: The mean change in best corrected visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) at Month 24 from Baseline [ Time Frame: 24 months ]
Original Primary Outcome: The mean change in best corrected visual acuity (Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from Baseline to Month 24 [ Time Frame: 24 months ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Ophthotech Corporation
Dates:
Date Received: February 16, 2016
Date Started: January 2016
Date Completion:
Last Updated: October 11, 2016
Last Verified: October 2016
