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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.
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Inclusion criteria
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. If both eyes have the same visual acuity, the right eye will be selected 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).
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:
Adequate clarity of ocular media, adequate pupillary dilation, and fixation to permit the collection of good quality images as determined by the Investigator.
Meets the following criteria related to microperimetry:
Female subjects must be:
Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
Willing and able to give informed consent and to comply with the study procedures and assessments.
Exclusion criteria
Ocular specific exclusion criteria apply to the study eye only, unless otherwise specified.
Primary purpose
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Interventional model
Masking
637 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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