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NCT06659549 · ClinicalTrials.gov registry record · Phase 2
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 study of Geographic Atrophy of the Macula, sponsored by Galimedix Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
- 14
- Study locations
NCT06659549: Recruiting Phase 2 study of Geographic Atrophy of the Macula, sponsored by Galimedix Therapeutics.
NCT06659549 is a Phase 2 study of Geographic Atrophy of the Macula that is actively recruiting participants, run by Galimedix Therapeutics. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). The trial reports 14 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06659549, a Phase 2 study of Geographic Atrophy of the Macula, is actively recruiting participants, sponsored by Galimedix Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
- 14
- Study locations
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.
Primary Outcome
Comparison between groups of annual rate of change in the area of GA as measured by fundus autofluorescence (FAF).
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 |
What NCT06659549 shows while recruiting
NCT06659549 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
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.
NCT06659549 lists 14 locations in 4 states (Other, California, Milano).
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.
What interventions are being tested in trial NCT06659549?
The interventions under investigation include: Placebo (DRUG), GAL-101 (DRUG).
Who is sponsoring clinical trial NCT06659549?
This trial is sponsored by Galimedix Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06659549's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,362 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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