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GALE


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
Therapeutic Area Macular Degeneration
Principal Investigator Caroline Baumal, MD
Min Age 60 Years
Gender All
Contact Nancy Gee
617-636-5489
neecresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04770545

Overview

This is a Phase 3, multicenter, 36-month, open-label extension study to assess the safety and efficacy of long-term IVT injections of pegcetacoplan in subjects with GA secondary to age-related macular degeneration (AMD).

Study Details

Inclusion Criteria

  • Participation in the parent study, APL2-304 (OAKS, NCT03525600)
  • Clarity of ocular media/adequate pupillary dilation

Exclusion Criteria

  • Permanent discontinuation from the parent study, OAKS
  • Presence of active ocular disease that confounds visual function

Study Requirements

The study will last up to three years. Subjects will continue on their treatment schedule (monthly vs. every other month) as assigned in the parent study, OAKS. Subjects will undergo visual acuity testing, dilated fundus examination, ocular imaging and intravitreal injection at each scheduled study visit. There are blood draws on Days 1, 180, 360, 540, 720, 900 and 1080.