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
Parallel
EG-301
DrugThe investigation drug, EG-301 Tablets 150mg, is for oral use.
AREDS2 supplements
Dietary supplementAREDS2 supplement is the stand of care
Adverse Events Assessment using CTCAE v5.0
Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTCAE v5.0, toxicities will be characterized in terms including seriousness, causality, toxicity grading, and action taken with regard to trial treatment.
GA lesion size change
The mean change in GA lesion size as measured by a) fundus autofluorescence (FAF) by an independent central reading center (CRC), and b) SD-OCT
Overall retinal sensitivity
Change in overall retinal sensitivity as measured by microperimetry using macular integrity assessment (MAIA)
BCVA in number of letters
The mean change in BCVA in the number of letters as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
Plasma levels of bioactive lipids
Changes in plasma levels of bioactive lipids, including sphingolipids, ceramides, and lysophosphatidic acids
Plasma levels of beclin-1 levels
Changes in plasma levels of beclin-1 levels as measured by the enzyme-linked immunosorbent assay (ELISA) method with a human beclin-1 ELISA kit
Complement factor levels
Changes in complement factor levels, including plasma concentrations of activation products C3d, Ba, C3a, C5a, and SC5b-9.
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