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

NCT06659549 | Recruiting Phase 2 FDA Drug

• 1 other identifier: GAL-101-C0201
• Study Type: interventional
• Target: 110
• Locations: 8 countries
• Sites: 14

Brief Summary

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

Geographic Atrophy of the Macula

Keywords

AMD; Geographic Atrophy; Age Related Macular Degeneration; Amyloid-Beta; Eye-drops

Outcome Measures

Primary Outcomes (1)

• Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size.

  Comparison between groups of annual rate of change in the area of GA as measured by fundus autofluorescence (FAF).

  From baseline to last on-treatment visit (48 up to 96 weeks)

Secondary Outcomes (1)

• Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in photoreceptor degeneration (PRD) in eyes with GA

  From baseline to last on-treatment visit (48 up to 96 weeks)

Study Arms (2)

GAL-101 ophthalmic solution

EXPERIMENTAL

Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval

Drug: GAL-101

Placebo

PLACEBO COMPARATOR

Patient will apply daily 2 eye drops ofPlacebo at 5 minutes interval

Drug: Placebo

Interventions

GAL-101 DRUG

Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval

GAL-101 ophthalmic solution

Placebo DRUG

Patient will apply daily 2 eye drops of Placebo at 5 minutes interval

Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Galimedix Therapeutics Inc: lead
• Lexitas Pharma Services, Inc.: collaborator

Study Sites (14)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

RECRUITING

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

RECRUITING

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

RECRUITING

Ophthalmological Center After S.V. Malayan

Yerevan, 0048, Armenia

RECRUITING

Centre Monticelli Paradis d'Ophtalmologie

Marseille, 13008, France

RECRUITING

Akhali Mzera Limited

Tbilisi, 0162, Georgia

RECRUITING

Caucasus Medical Centre LLC

Tbilisi, 0186, Georgia

RECRUITING

Chichua Medical Centre Mzera LLC

Tbilisi, Georgia

RECRUITING

Universitäts-Augenklinik Bonn

Bonn, 53127, Germany

RECRUITING

Institute of Eye Surgery (IOES Waterford)

Waterford, X91 DH9W, Ireland

RECRUITING

Hadassah Medical Center

Jerusalem, 9112001, Israel

RECRUITING

Tel Aviv Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe

Milan, Milano, 20123, Italy

RECRUITING

Unità di Oculistica, IRCCS Ospedale San Raffaele

Milan, Milano, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Galimedix Inc. c/o Imperial CRS, MD

CONTACT

+1 (301) 9179191; info@galimedix.com

Luciana Summo, PhD

CONTACT

info@galimedix.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Reading Centers
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 26, 2024
• Study Start: January 10, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

GE (3); AR (1); FR (1); DE (1); IT (2); IL (2); IE (1); US (3)