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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Geographic Atrophy of the Macula

In brief

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.

Key facts

Study ID

NCT06659549

Run by

Galimedix Therapeutics Inc

People needed

110

Starts

2025-01-10

Expected to finish

2027-05-30

Last updated by the study team

2026-08-06

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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
• Well-delineated cumulative GA area between 1.25 and 12.0 mm2
• If GA is multifocal, at least 1 lesion ≥1.25 mm2
• 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)
• GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea
• 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
• GA lesions must be >300 µm from the optic disc and/or peripapillary atrophy
• Area of PRD must be cumulatively between 7.25 and 25.0 mm2

You may not qualify if…

• Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline
• History of laser therapy in the macular region, regardless of indication
• History of herpes zoster
• Ophthalmic disease or condition that requires or is likely to require surgery during the study period
• GA with cumulative area <1.25 mm2
• Any GA lesion within 100 µm radius from the center point of the fovea
• Axial length >26 mm
• 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.)
• 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
• Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period
• Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period
• Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period
• Non-study Eye:
• BCVA of <5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent)
• Either Eye:
• History of uveitis
• GA secondary to any condition other than non-neovascular AMD
• History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline
• Underwent investigational treatment for AMD within 6 months before Visit 1a
• General Exclusion Criteria:
• History of therapeutic radiation to the cranium
• Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients
• History of malignant disease
• Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period
• Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period

Where it is running

• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States (enrolling)
• Bay Area Retina Associates — Walnut Creek, California, United States (enrolling)
• Unità di Oculistica, IRCCS Ospedale San Raffaele — Milan, Milano, Italy (enrolling)
• 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, Italy (enrolling)
• Ophthalmological Center After S.V. Malayan — Yerevan, Armenia (enrolling)
• Centre Rétine Gallien — Bordeaux, France (enrolling)
• Centre de Recherche Clinique du Groupement Hospitalier Nord — Lyon, France (enrolling)
• Centre Monticelli Paradis d'Ophtalmologie — Marseille, France (enrolling)
• Centre Ophtalmologique Saint Exupéry — Saint-Cyr-sur-Loire, France (enrolling)
• Akhali Mzera Limited — Tbilisi, Georgia (enrolling)
• Caucasus Medical Centre LLC — Tbilisi, Georgia (enrolling)
• Universitäts-Augenklinik Bonn — Bonn, Germany (enrolling)
• Universitätsklinikum Freiburg Klinik für Augenheilkunde — Freiburg im Breisgau, Germany (enrolling)
• Dietrich Bonhoeffer Klinikum — Neubrandenburg, Germany (enrolling)
• Institute of Eye Surgery (IOES Waterford) — Waterford, Ireland (enrolling)
• Hadassah Medical Center — Jerusalem, Israel (enrolling)
• Tel Aviv Medical Center — Tel Aviv, Israel (enrolling)
• Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe — Milan, Milano, Italy (enrolling)
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States
• Chichua Medical Centre Mzera LLC — Tbilisi, Georgia

Full record on ClinicalTrials.gov

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