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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm: AREDS2 supplements (SOC) | Active Comparator | All patients assigned to this Control Group will receive standard of care to include AREDS2 supplements daily throughout the study. |
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| Experomental Arm: AREDS2 supplements (SOC) plus EG-301 | Experimental | Patients assigned to the Experimental Group will receive a standard of care equivalent to that of the Control Group plus EG-DPMP-01 (150 mg daily, given at bedtime with a light snack). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EG-301 | Drug | The investigation drug, EG-301 Tablets 150mg, is for oral use. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | From baseline to Week 26 treatment period |
| Overall retinal sensitivity | Change in overall retinal sensitivity as measured by microperimetry using macular integrity assessment (MAIA) | 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 | 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 | From baseline to Week 26 treatment period |
| Binocular reading speed | Binocular reading speed as assessed by the Minnesota Low-Vision Reading Test (MNRead) Charts | From baseline to Week 26 treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of bioactive lipids | Changes in plasma levels of bioactive lipids, including sphingolipids, ceramides, and lysophosphatidic acids | From baseline to Week 26 treatment period |
| Plasma levels of beclin-1 levels |
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Key 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:
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:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Du, Ph.D. | Contact | 2404064016 | david.du@egpharm.com | |
| Charles Lee, M.D., Ph.D. | Contact | 2404064016 | charles.lee@egpharm.com |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| AREDS2 supplements | Dietary Supplement | AREDS2 supplement is the stand of care |
|
| Binocular critical print size |
Binocular critical print size as assessed by the Minnesota Low-Vision Reading Test (MNRead) Charts |
| From baseline to Week 26 treatment period |
| NEI-VFQ score | Change in NEI-VFQ score | From baseline to Week 26 treatment period |
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
| 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. | From baseline to Week 26 treatment period |