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

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 2

Age range

55 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

110 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Random assignment

Masking

Quadruple masked

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (24)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

24 locations

Study team and timeline

Lead sponsor

Galimedix Therapeutics Inc

Study start

Jan 10, 2025 Actual

Primary completion

Mar 30, 2028 Estimated

Study completion

May 30, 2028 Estimated

First posted

Oct 26, 2024 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts