At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 637 enrolled
Drug / intervention
APL-2 +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal Pegcetacoplan Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
In Brief
A Phase 3 clinical trial evaluating APL-2 and Sham Procedure for Geographic Atrophy. Completed, enrolled 637 participants across 112 sites in 14 countries.
Detailed Summary
This is a 24-month, Phase III, multicenter, randomized, double-masked, sham-injection controlled study to assess the efficacy and safety of multiple IVT injections of APL-2 in subjects with GA secondary to AMD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeographic Atrophy
CountriesAustralia, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, New Zealand, Poland, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartAug 2018
Primary CompletionJun 2021
Study CompletionJun 2022
TodayJul 2026
First PostedMay 15, 2018
Enrollment StartAug 31, 2018
Primary CompletionJun 28, 2021
Study CompletionJun 28, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 8.1 years ago
Interventions
APL-2drug
Complement (C3) Inhibitor
APL-2drug
Complement (C3) Inhibitor
Sham Procedureother
Subjects will receive a Sham procedure every month
Sham Procedureother
Subjects will receive a Sham procedure every other month