Research 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 Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Sponsor: Ophthotech Corporation
Principal Investigator: Atul Sharma, M.D.
Description: 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).
Approximately 300 subjects will be randomized in a 1:1:1 ratio to the following dose groups:
- Zimura® Dose 1
- Zimura® Dose 2
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.
Start Date: January 2016
Project Personnel: Leslie Marcus, CCRC; Caitlin Harrison, COA; Halie Sklanka, CRC
Location(s): Marietta, 833 Campbell Hill Street, Suite 300, Marietta, GA 30060