Actively Recruiting
A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
Led by Galimedix Therapeutics Inc · Updated on 2026-02-06
110
Participants Needed
14
Research Sites
124 weeks
Total Duration
On this page
Sponsors
G
Galimedix Therapeutics Inc
Lead Sponsor
L
Lexitas Pharma Services, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 55 years of age or older
- Willing and able to provide written informed consent
- Willing and able to comply with the study schedule and assessments
- Able to administer eye drops or have a designated person who can do so
- Best corrected visual acuity (BCVA) of 50 letters or more in the study eye
- Refractive error between +3 and -6 diopters spherical equivalent in the study eye
- Clear ocular media and adequate pupil dilation for quality imaging
- Diagnosed with non-foveal geographic atrophy secondary to non-neovascular age-related macular degeneration
- Well-defined GA area between 1.25 and 12.0 mm2; if multifocal, at least one lesion ≥1.25 mm2
- GA lesions located outside a 100 μm radius from the fovea center and within 2000 μm radius
- GA lesions fully within FAF imaging field and more than 300 μm from image edges
- GA lesions more than 300 μm from optic disc or peripapillary atrophy
- Peripheral retinal degeneration area between 7.25 and 25.0 mm2
You will not qualify if you...
- Presence or history of choroidal neovascularization
- History of laser therapy in the macular region
- History of herpes zoster
- Ophthalmic disease needing surgery during the study period
- GA area less than 1.25 mm2
- Any GA lesion within 100 μm radius of the fovea center
- Axial eye length greater than 26 mm
- Other ocular diseases affecting study assessments or adherence
- Intraocular surgery within 3 months or YAG surgery within 2 months before screening
- Use of pegcetacoplan or avacincaptad pegol within 6 months before screening
- Use of any ophthalmic medication or rigid contact lenses within 1 month before screening
- BCVA less than 5 letters in the non-study eye
- History of uveitis or active ocular infection/inflammation within 3 months
- GA caused by conditions other than non-neovascular AMD
- Prior investigational treatment for AMD within 6 months
- History of therapeutic cranial radiation
- Allergy to the study medication or its ingredients
- History of cancer
- Use of hydroxychloroquine within 1 month before screening
- Participation in another investigational medicinal product study within 1 month
- Use of lutein >10 mg/day or zeaxanthin >2 mg/day within 1 month
- Any medical or mental condition interfering with study participation
- Abnormal screening lab values making participation unsuitable
- Pregnant, nursing, or planning pregnancy during the study
- Unwilling or unable to use contraception if applicable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
Actively Recruiting
2
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
Actively Recruiting
3
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740
Actively Recruiting
4
Ophthalmological Center After S.V. Malayan
Yerevan, Armenia, 0048
Actively Recruiting
5
Centre Monticelli Paradis d'Ophtalmologie
Marseille, France, 13008
Actively Recruiting
6
Akhali Mzera Limited
Tbilisi, Georgia, 0162
Actively Recruiting
7
Caucasus Medical Centre LLC
Tbilisi, Georgia, 0186
Actively Recruiting
8
Chichua Medical Centre Mzera LLC
Tbilisi, Georgia
Actively Recruiting
9
Universitäts-Augenklinik Bonn
Bonn, Germany, 53127
Actively Recruiting
10
Institute of Eye Surgery (IOES Waterford)
Waterford, Ireland, X91 DH9W
Actively Recruiting
11
Hadassah Medical Center
Jerusalem, Israel, 9112001
Actively Recruiting
12
Tel Aviv Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
13
Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe
Milan, Milano, Italy, 20123
Actively Recruiting
14
Unità di Oculistica, IRCCS Ospedale San Raffaele
Milan, Milano, Italy, 20132
Actively Recruiting
Research Team
G
Galimedix Inc. c/o Imperial CRS, MD
CONTACT
L
Luciana Summo, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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