Non-Exudative (Dry) Age-related Macular Degeneration (dAMD)Phase 2NCT05170048
Study to Evaluate Safety and Efficacy of EG-301 in Patients With Nonfocal Geographic Atrophy Secondary to Dry-AMD
A Phase 2 study testing EG-301 and AREDS2 supplements in people with Non-Exudative (Dry) Age-related Macular Degeneration (dAMD), run by Evergreen Therapeutics, Inc..
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Non-Exudative (Dry) Age-related Macular Degeneration (dAMD)
- What is being tested?
- EG-301 and AREDS2 supplements
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Non-center involving GA lesions that reside completely within the FAF imaging field (field 2, 30 degree image centered on the fovea)
Show all 14Show fewer
- 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
- 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:
- The RPE and outer retinal layers throughout the central 1 mm are intact
- No signs of NVAMD such as intraretinal or sub retinal fluid, or sub retinal hyper-reflective material
- No serous pigment epithelium detachments >100 microns in height
- Sufficiently clear ocular media, adequate pupillary dilation, fixation to permit quality fundus imaging, and able to cooperate sufficiently for adequate ophthalmic visual function testing and anatomic assessment
Who cannot join
- 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
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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:
- AREDS2 supplements (Control Group, N=30)
- AREDS2 supplements plus EG-DPMP-01 150 mg daily (Experimental Group, N=60)
- Being tested
- EG-301, AREDS2 supplements
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EG-301Drug
The investigation drug, EG-301 Tablets 150mg, is for oral use.
AREDS2 supplementsDietary supplement
AREDS2 supplement is the stand of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: AREDS2 supplements |
| 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). Receives: Drug: EG-301; Dietary Supplement: AREDS2 supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From baseline to Week 26 treatment period
Overall retinal sensitivity
Change in overall retinal sensitivity as measured by microperimetry using macular integrity assessment (MAIA)
Measured: 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
Measured: 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
Measured: From baseline to Week 26 treatment period
Binocular reading speed
Binocular reading speed as assessed by the Minnesota Low-Vision Reading Test (MNRead) Charts
Measured: 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
Measured: From baseline to Week 26 treatment period
NEI-VFQ score
Change in NEI-VFQ score
Measured: From baseline to Week 26 treatment period
Secondary outcomes (3)
Plasma levels of bioactive lipids
Changes in plasma levels of bioactive lipids, including sphingolipids, ceramides, and lysophosphatidic acids
Measured: 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
Measured: 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.
Measured: From baseline to Week 26 treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Exudative (Dry) Age-related Macular Degeneration (dAMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evergreen Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170048
- Sponsor's protocol ID
- EG-301-2.1
- Status last verified
- Dec 2025
- First submitted
- 10 Dec 2021
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05170048
- Acronym / sponsor ID
- EG-301-2.1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Evergreen Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- AREDS2 supplements (Control Group, N=30)
- AREDS2 supplements plus EG-DPMP-01 150 mg daily (Experimental Group, N=60)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm: AREDS2 supplements (SOC) | Active comparator | Dietary Supplement: AREDS2 supplementsAll patients assigned to this Control Group will receive standard of care to include AREDS2 supplements daily throughout the study. |
| Experomental Arm: AREDS2 supplements (SOC) plus EG-301 | Experimental | Drug: EG-301, Dietary Supplement: AREDS2 supplementsPatients 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). |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EG-301The investigation drug, EG-301 Tablets 150mg, is for oral use. | Drug | Experomental Arm: AREDS2 supplements (SOC) plus EG-301 |
| AREDS2 supplementsAREDS2 supplement is the stand of care | Dietary supplement | Control Arm: AREDS2 supplements (SOC), Experomental Arm: AREDS2 supplements (SOC) plus EG-301 |
Primary outcome
Adverse Events Assessment using CTCAE v5.0
Time frame: Evaluation in 26 weeks treatment period, and 4 weeks safety follow up period.
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
Time frame: From baseline to Week 26 treatment period
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
Time frame: From baseline to Week 26 treatment period
Change in overall retinal sensitivity as measured by microperimetry using macular integrity assessment (MAIA)
BCVA in number of letters
Time frame: From baseline to Week 26 treatment period, and 4 weeks safety follow up period.
The mean change in BCVA in the number of letters as assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol
Low luminance visual acuity (LLVA)
Time frame: From baseline to Week 26 treatment period
The mean change in low luminance visual acuity (LLVA) in number of letters as assessed by the ETDRS protocol
Binocular reading speed
Time frame: From baseline to Week 26 treatment period
Binocular reading speed as assessed by the Minnesota Low-Vision Reading Test (MNRead) Charts
Binocular critical print size
Time frame: From baseline to Week 26 treatment period
Binocular critical print size as assessed by the Minnesota Low-Vision Reading Test (MNRead) Charts
NEI-VFQ score
Time frame: From baseline to Week 26 treatment period
Change in NEI-VFQ score
3 secondary outcomes
Plasma levels of bioactive lipids
Time frame: From baseline to Week 26 treatment period
Plasma levels of beclin-1 levels
Time frame: From baseline to Week 26 treatment period
Complement factor levels
Time frame: From baseline to Week 26 treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EG-301 and AREDS2 supplements in people with Non-Exudative (Dry) Age-related Macular Degeneration (dAMD), run by Evergreen Therapeutics, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xin Du, Ph.D. (2404064016, david.du@egpharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events Assessment using CTCAE v5.0 (time frame: Evaluation in 26 weeks treatment period, and 4 weeks safety follow up period.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.