Age-related Macular Degeneration // Clinical Trials // Geographic Atrophy // Mihai Mititelu // Past // Jun 12 2019
A Phase III, Multi-Center, Randomized, Double-Masked, Sham Controlled 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) (OAKS)
Sponsor: Apellis Pharmaceuticals, Inc.
Principal Investigator: Mihai Mititelu, MD, MPH
Study Coordinator: Chris Smith
To assess the efficacy and safety of multiple intravitreal injections of APL-2 in subjects with geographic atrophy secondary to age-related macular degeneration.
Participants will receive APL-2 or sham-control every 4 weeks or every 8 weeks over a 30-month period.
GALE is an open-label extension study and subjects must have participated in APL2-103 (NCT03777332) or completed the treatment at Month 24 of either APL2-303 (Derby, NCT03525613) or APL2-304 (Oaks, NCT03525600).
The study eye must meet all inclusion criteria. If both eyes meet the inclusion criteria, the eye with the worst visual acuity at the screening visit will be designated as the study eye.
Ocular- specific inclusion criteria apply to the study eye only, unless otherwise specified.
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)
The GA lesion must meet the following criteria as determined by the central reading center’s assessment of Fundus Autofluorescence (FAF) imaging at screening:
Total GA area must be ≥ 2.5 and ≤ 17.5 mm2 (1 and 7 disk areas [DA] respectively)
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
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
Presence of any pattern of hyperautofluorescence in the junctional zone of GA. Absence of hyperautofluorescence (i.e. pattern = none) is exclusionary.
Meets the following criteria related to microperimetry:
Able to detect fixation target
Total elapsed time to complete the 10-2 68 point exam is ≤ 30 minutes in duration
Reliability test ratio must be ≤ 20%
Subject is willing and able to undertake microperimetry assessment in the opinion of the investigator
Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.
Spherical equivalent of the refractive error demonstrating > 6 diopters of myopia or an axial length >26 mm
Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization
History of laser therapy in the macular region
Aphakia or absence of the posterior capsule. Note: YAG laser posterior capsulotomy for posterior capsule opacification done at least 60 days prior to screening is not exclusionary
History of prior intravitreal injection
Unable to perform microperimetry reliably in the opinion of the investigator