A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD (NCT06659549)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Retina-Vitreous Associates Medical Group — Beverly Hills, California
Age range: 55 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (25 Sites)
- Retina-Vitreous Associates Medical Group — Beverly Hills, California
- Bay Area Retina Associates — Walnut Creek, California
- Cumberland Valley Retina Consultants — Hagerstown, Maryland
- Ophthalmological Center After S.V. Malayan — Yerevan,
- Centre Rétine Gallien — Bordeaux,
- Hopital de La Croix-Rousse Service D'Ophtalmologie Groupement Hospitalier Nord Hospices Civils de Lyon — Lyon,
- Centre Monticelli Paradis d'Ophtalmologie — Marseille,
- Centre Ophtalmologique Odéon — Paris,
- Centre médico-chirurgical de Touraine — Tours,
- Akhali Mzera Limited — Tbilisi,
- Caucasus Medical Centre LLC — Tbilisi,
- Chichua Medical Centre Mzera LLC — Tbilisi,
- Universitäts-Augenklinik Bonn — Bonn,
- Universitätsklinikum Freiburg Klinik für Augenheilkunde — Freiburg im Breisgau,
- Medizinische Hochschule Hannover Augenklinik — Hanover,
- Dietrich Bonhoeffer Klinikum — Neubrandenburg,
- Universitätsklinikum Tübingen, Department für Augenheilkunde. — Tübingen,
- UNIVERSITÄTSKLINIKUM ULM Klinik für Augenheilkunde — Ulm,
- UPMC Kildare Hospital Prosperous Rd Clane, Kildare Ireland — Kildare,
- Institute of Eye Surgery (IOES Waterford) — Waterford,
- Hadassah Medical Center — Jerusalem,
- Tel Aviv Medical Center — Tel Aviv,
- Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe — Milan, Milano
- Unità di Oculistica, IRCCS Ospedale San Raffaele — Milan, Milano
- UOS Retina Medica, P.O. Britannico, IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in OftalmologiaUOS Retina Medica, P.O. Britannico, IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia — Roma, Roma
📞 Contact the Study Coordinator
Phone: (301) 917-9191
Email: info@galimedix.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.