GALE - Phase 3 GA Extension Study
Research type
Research Study
Full title
A Phase 3 open-label, multicenter, extension study to evaluate the long-term safety and efficacy of pegcetacoplan in subjects with geographic atrophy secondary to age-related macular degeneration.
IRAS ID
296863
Contact name
Ian Pearce
Contact email
Sponsor organisation
Apellis Pharmaceuticals, Inc.
Eudract number
2020-002931-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The purpose of this study is to continue evaluation of the long-term safety and efficacy of pegcetacoplan when it is given as an intravitreal injection to participants with Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD).
Currently, there is no effective treatment available for Geographic Atrophy secondary to Age-Related Macular Degeneration. Patients with GA generally lose vision due to death of cells in the retina, which leaves GA lesions. This study is being done to see if the drug, pegcetacoplan, may be able to slow down the growth of GA lesions.
The study will enroll approximately 1200 participants globally across approximately 250 sites that previously participated in a study evaluating pegcetacoplan for GA. Participation in the study will last up to 3 years.
Study procedures will include: physical examinations, blood sampling, complete ophthalmologic examinations, ocular imaging, and questionnaires completion.
This study is sponsored by Apellis Pharmaceuticals, Inc.REC name
North East - York Research Ethics Committee
REC reference
21/NE/0124
Date of REC Opinion
25 Aug 2021
REC opinion
Further Information Favourable Opinion