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 (AMD) APL2-304 OAKS

Active Clinical Trials // Jun 12 2019

Sponsor: Apellis Pharmaceuticals, Inc.
Principal Investigator: Mihai Mititelu, MD
Study Coordinator: Chris Smith

Study Objective:

This is a 30-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 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

Intervention: Drug: APL-2

 

  • 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

Intervention: Drug: APL-2

 

  • Experimental: Sham Procedure Monthly for 24 months

Sham Procedure monthly for 24 months

Intervention: Other: Sham Procedure

 

  • Experimental: Sham Procedure Every Other Month for 24 months

Sham Procedure every other month for 24 months

Intervention: Other: Sham Procedure

 

Diagnosis and Key Eligibility Criteria:

Age ≥ 60 years.

Normal Luminance best corrected visual acuity of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (approximately 20/320 Snellen equivalent).

Clinical diagnosis of GA of the macula secondary to AMD as determined by the Investigator and confirmed by the Reading Center.

The GA lesion must meet the following criteria as determined by the central reading center’s assessment of Fundus Autofluorescence (FAF) imaging at screening:

  1. Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively)
  2. If GA is multifocal, at least one focal lesion must be ≥ 1.25 mm2 (0.5 DA), with the overall aggregate area of GA, as specified above in 4a.
  3. The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
  4. Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.

 

Duration of Study: 24 months 

For more information, contact Chris Smith at 608-263-7169.