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

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

Jun 2023

Primary completion

Jun 28, 2021

Completion

Jun 28, 2022

Study Design

Enrollment

637 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 monthly 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 (67)

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