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A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
NCT06659549 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GAL-101
Study Locations (14)
Other
- Ophthalmological Center After S.V. Malayan — Yerevan
- Centre Monticelli Paradis d'Ophtalmologie — Marseille
- Akhali Mzera Limited — Tbilisi
- Caucasus Medical Centre LLC — Tbilisi
- Chichua Medical Centre Mzera LLC — Tbilisi
- Universitäts-Augenklinik Bonn — Bonn
- Institute of Eye Surgery (IOES Waterford) — Waterford
- Hadassah Medical Center — Jerusalem
- Tel Aviv Medical Center — Tel Aviv
California
- Retina-Vitreous Associates Medical Group — Beverly Hills
- Bay Area Retina Associates — Walnut Creek
Milano
- Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe — Milan
- Unità di Oculistica, IRCCS Ospedale San Raffaele — Milan
Maryland
- Cumberland Valley Retina Consultants — Hagerstown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2025-01-10 |
| Est. Completion | 2027-05-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06659549
The ClinicalTrials.gov registry entry for NCT06659549 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galimedix Therapeutics, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Geographic Atrophy of the Macula appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06659549 reports 14 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Milano. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06659549 about?
NCT06659549 is a clinical study titled "A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD". 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 sma...
What is the current status of trial NCT06659549?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2025-01-10. Estimated completion is 2027-05-30.
What conditions does trial NCT06659549 study?
This clinical trial studies the following conditions: Geographic Atrophy of the Macula. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06659549?
The interventions under investigation include: Placebo (DRUG), GAL-101 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06659549?
This trial is sponsored by Galimedix Therapeutics, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06659549 being conducted?
This trial has 14 study locations across California, Maryland, Milano. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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