Study to Evaluate Safety and Efficacy of EG-301 in Patients With Nonfocal Geographic Atrophy Seco… (NCT05170048) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study to Evaluate Safety and Efficacy of EG-301 in Patients With Nonfocal Geographic Atrophy Secondary to Dry-AMD
90 participantsStarted 2026-06
Plain-language summary
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)
Who can participate
Age range50 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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
✓. Subjects with confirmed diagnosis of geographic atrophy (GA) secondary to dAMD in the study eye\* as evidenced by the following characteristics:
Exclusion criteria
✕. Subjects with evidence of reasonably well-preserved areas of RPE by clinical examination and well-defined RPE and outer segment ellipsoid line by OCT examination in the central 1 mm of the macula as confirmed by the central reading center. More specifically, reasonably well- preserved central 1 mm of the macula means:
✕. 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.
✕
What they're measuring
1
Adverse Events Assessment using CTCAE v5.0
Timeframe: Evaluation in 26 weeks treatment period, and 4 weeks safety follow up period.
2
GA lesion size change
Timeframe: From baseline to Week 26 treatment period
3
Overall retinal sensitivity
Timeframe: From baseline to Week 26 treatment period
4
BCVA in number of letters
Timeframe: From baseline to Week 26 treatment period, and 4 weeks safety follow up period.
5
Low luminance visual acuity (LLVA)
Timeframe: From baseline to Week 26 treatment period
6
Binocular reading speed
Timeframe: From baseline to Week 26 treatment period
7
Binocular critical print size
Timeframe: From baseline to Week 26 treatment period
8
NEI-VFQ score
Timeframe: From baseline to Week 26 treatment period
. 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
✕. Subjects who have received any drug or herbal medicine known to inhibit CYP2D6 enzyme activity prior to the first dose of the investigational drug (the patient can be enrolled if the washout period is ≥5 half-lives of the CYP2D6 inhibitor), or subjects who need to continue receiving these medications during the study period. (Refer to Appendix 1 for a list of CYP2D6 inhibitors)
✕. Subjects with moderate or severe renal impairment as indicated by an estimated glomerular filtration rate (eGFR) \<60 mL/min, calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)