NCT03525613

A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 637 (actual)
• Sponsor: Apellis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Geographic Atrophy

Interventions

Type	Name	Description
DRUG	APL-2	Complement (C3) Inhibitor
DRUG	APL-2	Complement (C3) Inhibitor
OTHER	Sham Procedure	Subjects will receive a Sham procedure every month
OTHER	Sham Procedure	Subjects will receive a Sham procedure every other month

Timeline

• Start date: 2018-08-31
• Primary completion: 2021-06-28
• Completion: 2022-06-28
• First posted: 2018-05-15
• Last updated: 2023-07-06
• Results posted: 2023-07-06

Locations

112 sites across 14 countries: United States, Australia, Brazil, Canada, Czechia, France, Germany, Israel, Italy, Netherlands, New Zealand, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study