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

Conditions

• Geographic Atrophy

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Aug 31, 2018

Status verified

May 2023

Primary completion

Jun 21, 2021

Completion

Jun 20, 2022

Study Design

Enrollment

621 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: APL-2 15mg 0.1 mL monthly for 24 months
  A single dose of 15 mg APL-2/0.1 mL will be administered via intravitreal injection in this study. Subjects will receive an injection every month
• Experimental: APL-2 15mg 0.1 mL EOM for 24 months
  A single dose of 15 mg APL-2/0.1 mL will be administered via intravitreal injection in this study. Subjects will receive an injection every other month
• Experimental: Sham Procedure Monthly for 24 months
  Sham Procedure for 24 months
• Experimental: Sham Procedure Every Other Month for 24 months
  Sham Procedure every other month for 24 months

Primary Outcome Measure

Least Squares (LS) Mean Change From Baseline in Total Area of GA Lesions in the Study Eye at Month 12 [ Time Frame: Baseline (screening) and Month 12 ]

Locations (73)

Find similar trials in Phoenix, AZ

Related Studies

• High Resolution Retinal Imaging
  Recruiting · University of Pennsylvania · Philadelphia, Pennsylvania
• Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
  PHASE1/PHASE2 · Recruiting · National Eye Institute (NEI) · Baltimore, Maryland
• Multicenter Clinical Study of the SING-IMT in Patients with Late-stage AMD
  Recruiting · VisionCare, Inc. · Loma Linda, California
• A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251
  PHASE2 · Recruiting · Genentech, Inc. · Beverly Hills, California