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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
The investigation drug, EG-301 Tablets 150mg, is for oral use.
AREDS2 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.
Time frame: Evaluation in 26 weeks treatment period, and 4 weeks safety follow up period.
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
Time frame: From baseline to Week 26 treatment period
Overall retinal sensitivity
Change in overall retinal sensitivity as measured by microperimetry using macular integrity assessment (MAIA)
Time frame: From baseline to Week 26 treatment period
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
Time frame: From baseline to Week 26 treatment period, and 4 weeks safety follow up period.
Low luminance visual acuity (LLVA)
The mean change in low luminance visual acuity (LLVA) in number of letters as assessed by the ETDRS protocol
Time frame: From baseline to Week 26 treatment period
Binocular reading speed
Binocular reading speed as assessed by the Minnesota Low-Vision Reading Test (MNRead) Charts
Time frame: From baseline to Week 26 treatment period
Binocular critical print size
Binocular critical print size as assessed by the Minnesota Low-Vision Reading Test (MNRead) Charts
Time frame: From baseline to Week 26 treatment period
NEI-VFQ score
Change in NEI-VFQ score
Time frame: From baseline to Week 26 treatment period
Plasma levels of bioactive lipids
Changes in plasma levels of bioactive lipids, including sphingolipids, ceramides, and lysophosphatidic acids
Time frame: From baseline to Week 26 treatment period
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
Time frame: From baseline to Week 26 treatment period
Complement factor levels
Changes in complement factor levels, including plasma concentrations of activation products C3d, Ba, C3a, C5a, and SC5b-9.
Time frame: From baseline to Week 26 treatment period
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