Clinical Trial: Study of of APL-2 Therapy in Patients Geographic Atrophy

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients Geographic At

Brief Summary: The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of APL-2 in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).

Detailed Summary:

This is a Phase II, prospective, multicenter, randomized, single-masked, sham-controlled study to assess the safety, tolerability and evidence of activity of multiple IVT injections of APL-2 in subjects with GA associated with Age-Related Macular Degeneration.

Patients diagnosed with GA associated with age-related macular degeneration in the study eye and who meet all inclusion/exclusion criteria will be included in the study. The study will randomize approximately 240 subjects to obtain at least 200 evaluable subjects across 40 multinational sites.

Subjects should be screened within 14 days before receiving APL-2. Upon entry into the study, subjects will be assigned a screening number. Patients who meet all inclusion and exclusion criteria and are confirmed as eligible by the CRC will return to the clinic for randomization and treatment on visit 2 (Day 0). At this visit, subjects will be randomized in a 2:2:1:1 manner to receive APL 2 Monthly (AM), APL-2 Every-Other-Month (AEOM), Sham injection Monthly (SM) or Sham injection Every-Other-Month (SEOM), respectively.

All subjects will return to the clinical site on Day 7 to assess acute safety after the first injection. After that, subjects in the monthly groups will return to the clinical site for additional APL-2 (or Sham) injections and study procedures every month until Month 12. Subjects in the Every-Other-Month groups will return to the clinical site for additional APL-2 (or Sham) injections and study procedures every two months until Month 12. All subjects will return for follow-up visits on Months 15 and 18 (3 and 6 months after last injection, respectively).


Sponsor: Apellis Pharmaceuticals, Inc.

Current Primary Outcome:

  • Primary Efficacy Endpoint: The primary endpoint is the change in square root geographic atrophy (GA) lesion size from baseline at month 12 as measured by FAF. [ Time Frame: 12 months from baseline ]
  • Primary Safety Endpoint: Number of local and systemic treatment emergent averse events (TEAE). [ Time Frame: 12 months from baseline ]
  • Primary Safety Endpoint: Severity of local and systemic treatment emergent averse events (TEAE). [ Time Frame: 12 months from baseline ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Apellis Pharmaceuticals, Inc.

Dates:
Date Received: July 14, 2015
Date Started: September 2015
Date Completion:
Last Updated: October 20, 2016
Last Verified: October 2016