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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD

A Phase 2, Double-masked, Randomized, Multicenter, Parallel Group, Placebo-controlled Study to Investigate the Efficacy and Safety of GAL-101, 2%, Ophthalmic Solution in Patients With Non-foveal Geographic Atrophy Secondary to Non-neovascular Age-related Macular Degeneration: eDREAM Study

A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD (NCT06659549) is a Phase 2 interventional studying Geographic Atrophy of the Macula, sponsored by Galimedix Therapeutics Inc. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the growth of GA and prevent it from reaching the fovea. GAL-101 is given as eyedrops. eDREAM patients will administer study eyedrops every day. Patients will be assigned by chance (randomly) to receive either eye-drops that contain the new medication, GAL-101, or eyedrops without the active drug (Placebo). Neither patients nor doctors will know which treatment was assigned to each patient until the end of the study.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Geographic Atrophy of the Macula and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 110 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Geographic Atrophy of the Macula subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - ≥55 years of age - Willing and able to provide written willing to sign a consent form - Willing and able to comply with the study schedule and study assessments - Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution - BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmed at Baseline - Refractive error between +3 and -6 diopters spherical equivalent in the study eye - Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline - Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center 1. Well-delineated cumulative GA area between 1.25 and 12.0 mm2 2. If GA is multifocal, at least 1 lesion ≥1.25 mm2 3. GA lesions must be located outside a ≥100 µm radius from the center point of the fovea (i.e., this area must have intact retinal pigment epithelium \[RPE\] and outer retina) 4. GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea 5. GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be \>300 µm from image edges 6. GA lesions must be \>300 µm from the optic disc and/or peripapillary atrophy 7. Area of PRD must be cumulatively between 7.25 and 25.0 mm2 Who Should NOT Join This Trial: 1. Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline 2. History of laser therapy in the macular region, regardless of indication 3. History of herpes zoster 4. Ophthalmic disease or condition that requires or is likely to require surgery during the study period ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * ≥55 years of age * Willing and able to provide written informed consent * Willing and able to comply with the study schedule and study assessments * Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution * BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmed at Baseline * Refractive error between +3 and -6 diopters spherical equivalent in the study eye * Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline * Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center 1. Well-delineated cumulative GA area between 1.25 and 12.0 mm2 2. If GA is multifocal, at least 1 lesion ≥1.25 mm2 3. GA lesions must be located outside a ≥100 µm radius from the center point of the fovea (i.e., this area must have intact retinal pigment epithelium \[RPE\] and outer retina) 4. GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea 5. GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be \>300 µm from image edges 6. GA lesions must be \>300 µm from the optic disc and/or peripapillary atrophy 7. Area of PRD must be cumulatively between 7.25 and 25.0 mm2 Exclusion Criteria: 1. Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline 2. History of laser therapy in the macular region, regardless of indication 3. History of herpes zoster 4. Ophthalmic disease or condition that requires or is likely to require surgery during the study period 5. GA with cumulative area \<1.25 mm2 6. Any GA lesion within 100 µm radius from the center point of the fovea 7. Axial length \>26 mm 8. Any ocular disease or condition other than non-neovascular AMD that may, in the opinion of the Investigator, interfere with study assessments, patient adherence to the study schedule, or interpretation of study data (e.g., epiretinal membrane, macular hole, glaucomatous optic neuropathy, etc.) 9. Intraocular surgery (including cataract extraction and crystalline lens replacement) within 3 months before Visit 1a or yttrium aluminum garnet (YAG) surgery within 2 months before Visit 1a, or planned either during the study period 10. Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period 11. Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period 12. Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period Non-study Eye: 13. BCVA of \<5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent) Either Eye: 14. History of uveitis 15. GA secondary to any condition other than non-neovascular AMD 16. History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline 17. Underwent investigational treatment for AMD within 6 months before Visit 1a General Exclusion Criteria: 18. History of therapeutic radiation to the cranium 19. Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients 20. History of malignant disease 21. Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period 22. Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period 23. Use of lutein \>10 mg per day or zeaxanthin \>2 mg per day within 1 month before Visit 1a, or planned use during the study period 24. Any medical condition (including mental), in the opinion of the Investigator, that could interfere with study assessments, patient adherence to the study schedule, or interpretation of study data 25. Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation 26. Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline 27. Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP) or if a sexual partner of a WOCBP

Treatments Being Tested

DRUG

GAL-101

Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval

DRUG

Placebo

Patient will apply daily 2 eye drops of Placebo at 5 minutes interval

Locations (14)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Ophthalmological Center After S.V. Malayan
Yerevan, Armenia
Centre Monticelli Paradis d'Ophtalmologie
Marseille, France
Akhali Mzera Limited
Tbilisi, Georgia
Caucasus Medical Centre LLC
Tbilisi, Georgia
Chichua Medical Centre Mzera LLC
Tbilisi, Georgia
Universitäts-Augenklinik Bonn
Bonn, Germany
Institute of Eye Surgery (IOES Waterford)
Waterford, Ireland
Hadassah Medical Center
Jerusalem, Israel
Tel Aviv Medical Center
Tel Aviv, Israel
Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe
Milan, Milano, Italy
Unità di Oculistica, IRCCS Ospedale San Raffaele
Milan, Milano, Italy

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06659549), the sponsor (Galimedix Therapeutics Inc), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06659549 clinical trial studying?

Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina. This means that there is an area with a loss of light-sensitive cells, called photoreceptors. That part of the retina can no longer see. Atrophy begins as a small spot in the retina distant from the fovea which is the part of the retina responsible for sharp central vision. The GA grows, and when it reaches the fovea, vision is severely diminished, and details cannot be seen anymore. The purpose of the eDREAM study is to understand if GAL-101 can slow the … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06659549?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06659549?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06659549. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06659549. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.