Study of Pegcetacoplan (APL-2) Therapy in Patients With Geographic Atrophy

Conditions

• Geographic Atrophy

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pegcetacoplan — DRUG
• Sham Procedure — OTHER

Study Details

The primary objectives of the study are to assess the safety, tolerability and evidence of activity of multiple intravitreal (IVT) injections of pegcetacoplan in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).

Key Dates

Start date

Sep 24, 2015

Status verified

Sep 2020

Primary completion

Jul 14, 2017

Completion

Jan 17, 2018

Study Design

Enrollment

246 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pegcetacoplan 15 mg/100 µL Monthly for 12 months
  A single dose of 15 mg pegcetacoplan/100 µL will be administered via intravitreal injection in this study. Subjects will receive an injection every month for 12 consecutive months.
• Experimental: Pegcetacoplan 15 mg/100 µL EOM for 12 months
  A single dose of 15 mg pegcetacoplan/100 µL will be administered via intravitreal injection in this study. Subjects will receive an injection every other month (EOM) for 12 consecutive months.
• Sham Comparator: Sham Monthly for 12 months
  Subjects will receive a Sham procedure every month for 12 consecutive months.
• Sham Comparator: Sham EOM for 12 months
  Subjects will receive a Sham procedure every other month (EOM) for 12 consecutive months.

Primary Outcome Measure

Least Square (LS) Mean Change From Baseline in Square Root GA Lesion Size in the Study Eye at Month 12 [ Time Frame: Baseline (screening) and Month 12. ]

Locations (35)

Find similar trials in Mobile, AL

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