This is a parallel, randomized, open-label, controlled study to evaluate the efficacy and safety of oral EG-301 in patients with intermediate non-exudative (dry) age-related macular degeneration (dAMD).
Ninety patients will be randomly allocated in a 2:1 ratio to one of two treatment arms for at least 6 months duration. The two treatment arms are:
1. AREDS2 supplements (Control Group, N=30) 2. AREDS2 supplements plus EG-DPMP-01 150 mg daily (Experimental Group, N=60)
Male or female patients, 50 to 75 years of age at screening visit
Subject has signed the Informed Consent form
Subjects with intermediate nonfocal geographic atrophy secondary to Non-Exudative (dry) AMD having ETDRS BCVA between 35 and 80 letters read (equivalent to 20/25 - 20/200 on Snellen Chart) with the level of vision caused by the non-exudative AMD and no other factor/s
Subjects with symptomatic decrease in visual acuity in the last 12 months
Females who are pregnant, nursing, planning a pregnancy during the study or who are of childbearing potential not using a reliable method of contraception and/or not willing to maintain a reliable method of contraception during their participation in the study. Women of childbearing potential with a positive urine pregnancy test administered at baseline are not eligible to receive study drug
Prior cataract surgery is allowed up to 90 days before the baseline visit, but refractive surgery in either eye may not be conducted during the study.
Subject with exudative AMD or choroidal neovascularization (CNV), including any evidence of retinal pigment epithelium rips, detachments or evidence of neovascularization anywhere in either eye based on SD-OCT imaging and/or fluorescein angiography as assessed by the Reading Center
Subjects who had anti-VEGF IVT in either eye in the past 90 days