Trials / Completed
CompletedNCT02503332
Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy
A Phase II, Multicenter, Randomized, Single-Masked, Sham-Controlled Study of Safety, Tolerability and Evidence of Activity of Intravitreal APL-2 Therapy in Patients With Geographic Atrophy (GA)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 246 (actual)
- Sponsor
- Apellis Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of pegcetacoplan in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).
Detailed description
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 pegcetacoplan in subjects with GA secondary to Age-Related Macular Degeneration. The study will randomize approximately 240 subjects to obtain at least 200 evaluable subjects across 40 multinational sites. Subjects will be randomized in a 2:2:1:1 manner to receive pegcetacoplan Monthly (AM), pegcetacoplan 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 pegcetacoplan (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 pegcetacoplan (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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pegcetacoplan | |
| OTHER | Sham Procedure |
Timeline
- Start date
- 2015-09-24
- Primary completion
- 2017-07-14
- Completion
- 2018-01-17
- First posted
- 2015-07-20
- Last updated
- 2020-10-06
- Results posted
- 2020-10-06
Locations
46 sites across 3 countries: United States, Australia, New Zealand
Source: ClinicalTrials.gov record NCT02503332. Inclusion in this directory is not an endorsement.