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Study to Evaluate Safety and Efficacy of EG-301 in Patients With Nonfocal Geographic Atrophy Secondary to Dry-AMD | Clinical Trials | Clareo Health

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Study to Evaluate Safety and Efficacy of EG-301 in Patients With Nonfocal Geographic Atrophy Secondary to Dry-AMD

A Phase 2, Parallel, Randomized, Open-label, Controlled Study of EG-301 150 mg Daily in Patients With Nonfocal Geographic Atrophy Secondary to Dry-AMD

NCT05170048•Evergreen Therapeutics, Inc.

View on ClinicalTrials.gov

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)

Eligibility

Age

50 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female patients, 50 to 75 years of age at screening visit
•2. Subject has signed the Informed Consent form
•3. 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
•4. Subjects with symptomatic decrease in visual acuity in the last 12 months
•5. Subjects with confirmed diagnosis of geographic atrophy (GA) secondary to dAMD in the study eye\* as evidenced by the following characteristics:
•* Non-center involving GA lesions that reside completely within the FAF imaging field (field 2, 30 degree image centered on the fovea)
•* Total GA area is ≥2.5 and ≤ 17.5 mm2 (1 and 7 disk areas \[DA\])
•* If GA is multifocal, at least one focal lesion must be \>1.25 mm2 (0.5 DA)
•* Combination of areas of RPE disturbances described as a pattern of hyper or hypo-pigmentation in the junctional zone of GA. Absence of hyper-autofluorescence is exclusionary
•6. 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:
+4 more criteria

Exclusion Criteria

•2. 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.
•3. 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
•4. Subjects who had anti-VEGF IVT in either eye in the past 90 days
•5. 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)
•6. 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)

Key Dates

Start Date

June 1, 2026

Primary Completion Date

June 1, 2028

Completion Date

June 1, 2028

Last Updated

December 8, 2025

Enrollment

ESTIMATED participants

Conditions

Non-Exudative (Dry) Age-related Macular Degeneration (dAMD)

Interventions

EG-301

DRUG

AREDS2 supplements

DIETARY_SUPPLEMENT

Contacts

Xin Du, Ph.D.

CONTACT

2404064016 david.du@egpharm.com

Charles Lee, M.D., Ph.D.

CONTACT

2404064016 charles.lee@egpharm.com