Testing GAL-101 eye drops for slowing vision loss in age-related macular degeneration

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

This study is testing if a new eye drop called GAL-101 can help slow down vision loss in people with a specific type of age-related macular degeneration.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 55 Years and up
• Sex: All
• Sponsor: Galimedix Therapeutics Inc (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 14 sites (Beverly Hills, California and 13 other locations)
• Trial ID: NCT06659549 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of GAL-101, a 2% ophthalmic solution, in patients with non-foveal geographic atrophy (GA) secondary to non-neovascular age-related macular degeneration (AMD). Participants will randomly receive either GAL-101 or a placebo and will administer the eye drops daily under supervision. The study aims to determine if GAL-101 can slow the progression of GA and prevent it from affecting central vision. The treatment period will last between 12 to 24 months, with regular assessments to monitor safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 55 and older diagnosed with non-foveal geographic atrophy secondary to non-neovascular AMD.

Not a fit: Patients with foveal geographic atrophy or those unable to administer eye drops may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly slow vision loss in patients with geographic atrophy due to AMD.

How similar studies have performed: Other studies have explored treatments for geographic atrophy, but the specific approach using GAL-101 is novel.

Eligibility criteria

Inclusion Criteria:

* ≥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

  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:

1. Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline
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

    General Exclusion Criteria:
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

Where this trial is running

Beverly Hills, California and 13 other locations

• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States (Recruiting)
• Bay Area Retina Associates — Walnut Creek, California, United States (Recruiting)
• Cumberland Valley Retina Consultants — Hagerstown, Maryland, United States (Recruiting)
• Ophthalmological Center After S.V. Malayan — Yerevan, Armenia (Recruiting)
• Centre Monticelli Paradis d'Ophtalmologie — Marseille, France (Recruiting)
• Akhali Mzera Limited — Tbilisi, Georgia (Recruiting)
• Caucasus Medical Centre LLC — Tbilisi, Georgia (Recruiting)
• Chichua Medical Centre Mzera LLC — Tbilisi, Georgia (Recruiting)
• Universitäts-Augenklinik Bonn — Bonn, Germany (Recruiting)
• Institute of Eye Surgery (IOES Waterford) — Waterford, Ireland (Recruiting)
• Hadassah Medical Center — Jerusalem, Israel (Recruiting)
• Tel Aviv Medical Center — Tel Aviv, Israel (Recruiting)
• Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe — Milan, Milano, Italy (Recruiting)
• Unità di Oculistica, IRCCS Ospedale San Raffaele — Milan, Milano, Italy (Recruiting)

Study contacts

• Study coordinator: Galimedix Inc. c/o Imperial CRS, MD

Conditions Geographic Atrophy of the Macula; AMD; Geographic Atrophy; Age Related Macular Degeneration; Amyloid-Beta; Eye-drops