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
Phase of Trial: Phase II/III
Latest Information Update: 08 Nov 2017
At a glance
- Drugs Avacincaptad pegol (Primary)
- Indications Dry age-related macular degeneration
- Focus Adverse reactions; Therapeutic Use
- Sponsors OphthoTech Corporation
- 08 Nov 2017 According to an OphthoTech Corporation media release, the Company submitted a modified Phase 2b clinical trial protocol to the US FDA early in the fourth quarter of 2017. Initial, top-line data from this trial are expected to be available during the second half of 2019.
- 08 Nov 2017 According to an OphthoTech Corporation media release, the company has modified the design of the trial to accelerate the anticipated timeline for obtaining top-line data. The Company has reduced the number of patients it plans to enroll in this trial to approximately 200 and has shortened the time point for attaining the primary efficacy endpoint to 12 months.
- 08 Nov 2017 Planned number of patients changed from 900 to 200 according to an OphthoTech Corporation media release,