A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
NCT ID: NCT06659549
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
110 participants
INTERVENTIONAL
2025-01-10
2027-05-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Investigating the Safety and Efficacy of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT02247531
A Study of NGM621 in Participants With Geographic Atrophy
NCT04465955
Intravitreal Injections of Sirolimus in the Treatment of Geographic Atrophy
NCT01675947
A Study Investigating the Efficacy and Safety of Lampalizumab Intravitreal Injections in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT02247479
Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
NCT00658619
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
During visits, patients will administer 3 applications of 1 drop of GAL-101 or a matching Placebo that does not contain the active pharmaceutical ingredient (API) at 5-minute intervals (i.e., 1st application, wait 5 minutes, 2nd application, wait 5 minutes, 3rd application), under the supervision of trained and authorized study personnel. In between visits, patients will be instructed to administer 2 applications of 1 drop at 5-minute intervals once a day.
The study will be comprised of a 12- to 24-month treatment period determined individually according to patients' overall placement in global study randomization. All patients will participate at least 12 months of treatment. The visit schedule includes the following: Screening visits (Visit 1a and 1b) for image capture and confirmation of study eligibility by a reading center; Baseline/Randomization/Day 1 (Visit 2); a phone call at 2 weeks; and on-treatment clinic visits for safety and efficacy evaluations at 1 month, 3 months, 6 months, 9 months, and 12 months. Patients will continue to attend on-treatment clinic visits at 3-month intervals after 12 months until the last patient randomized in the study has completed 12 months of study treatment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
GAL-101 ophthalmic solution
Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
GAL-101
Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
Placebo
Patient will apply daily 2 eye drops ofPlacebo at 5 minutes interval
Placebo
Patient will apply daily 2 eye drops of Placebo at 5 minutes interval
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
GAL-101
Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
Placebo
Patient will apply daily 2 eye drops of Placebo at 5 minutes interval
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
1. Well-delineated cumulative GA area between 1.25 and 12.0 mm2
2. If GA is multifocal, at least 1 lesion ≥1.25 mm2
3. 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)
4. GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea
5. 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
6. GA lesions must be \>300 µm from the optic disc and/or peripapillary atrophy
7. Area of PRD must be cumulatively between 7.25 and 25.0 mm2
Exclusion Criteria
2. History of laser therapy in the macular region, regardless of indication
3. History of herpes zoster
4. Ophthalmic disease or condition that requires or is likely to require surgery during the study period
5. GA with cumulative area \<1.25 mm2
6. Any GA lesion within 100 µm radius from the center point of the fovea
7. Axial length \>26 mm
8. 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.)
9. 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
10. Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period
11. Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period
12. Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period
Non-study Eye:
13. BCVA of \<5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent)
Either Eye:
14. History of uveitis
15. GA secondary to any condition other than non-neovascular AMD
16. History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline
17. Underwent investigational treatment for AMD within 6 months before Visit 1a
18. History of therapeutic radiation to the cranium
19. Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients
20. History of malignant disease
21. Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period
22. Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period
23. Use of lutein \>10 mg per day or zeaxanthin \>2 mg per day within 1 month before Visit 1a, or planned use during the study period
24. Any medical condition (including mental), in the opinion of the Investigator, that could interfere with study assessments, patient adherence to the study schedule, or interpretation of study data
25. Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation
26. Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline
27. Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP) or if a sexual partner of a WOCBP
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lexitas Pharma Services, Inc.
INDUSTRY
Galimedix Therapeutics Inc
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Ophthalmological Center After S.V. Malayan
Yerevan, , Armenia
Centre Monticelli Paradis d'Ophtalmologie
Marseille, , France
Akhali Mzera Limited
Tbilisi, , Georgia
Caucasus Medical Centre LLC
Tbilisi, , Georgia
Chichua Medical Centre Mzera LLC
Tbilisi, , Georgia
Universitäts-Augenklinik Bonn
Bonn, , Germany
Institute of Eye Surgery (IOES Waterford)
Waterford, , Ireland
Hadassah Medical Center
Jerusalem, , Israel
Tel Aviv Medical Center
Tel Aviv, , Israel
Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe
Milan, Milano, Italy
Unità di Oculistica, IRCCS Ospedale San Raffaele
Milan, Milano, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GAL-101-C0201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.