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

February 5, 2026 updated by: Galimedix Therapeutics Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, if both eyes qualify for the study, the eye with the better BCVA will be defined as the study eye. If both eyes qualify for the study and have identical BCVA, then the eye with higher baseline peripheral retinal degenerations (PRD) will be defined as the study eye. If baseline PRD is identical, then the right eye (OD) will be defined as the study eye. Only the study eye will be dosed with the Investigation Medicinal Product (IMP).

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Galimedix Inc. c/o Imperial CRS, MD
  • Phone Number: +1 (301) 9179191
  • Email: info@galimedix.com

Study Contact Backup

Study Locations

  • Armenia
      • Yerevan, Armenia, 0048
        • Recruiting
        • Ophthalmological Center After S.V. Malayan
        • Contact:
        • Principal Investigator:
          • Lilit Voskanyan, MD, PhD
  • France
      • Marseille, France, 13008
        • Recruiting
        • Centre Monticelli Paradis d'Ophtalmologie
        • Contact:
        • Principal Investigator:
          • François Devin, MD
  • Georgia
      • Tbilisi, Georgia, 0186
        • Recruiting
        • Caucasus Medical Centre Llc
        • Contact:
        • Principal Investigator:
          • Mikheil Omiadze, MD, PhD
      • Tbilisi, Georgia, 0162
        • Recruiting
        • Akhali Mzera Limited
        • Contact:
        • Principal Investigator:
          • Shalva Skhirtladze, MD
      • Tbilisi, Georgia
        • Recruiting
        • Chichua Medical Centre Mzera LLC
        • Contact:
        • Principal Investigator:
          • George Chichua, MD, PhD
  • Germany
      • Bonn, Germany, 53127
        • Recruiting
        • Universitäts-Augenklinik Bonn
        • Principal Investigator:
          • Kristina Pfau, MD
        • Contact:
  • Ireland
      • Waterford, Ireland, X91 DH9W
        • Recruiting
        • Institute of Eye Surgery (IOES Waterford)
        • Contact:
        • Principal Investigator:
          • Eugene Ng, MD
  • Israel
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center
        • Contact:
        • Principal Investigator:
          • Tareq Jaouni, MD
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Medical Center
        • Contact:
        • Principal Investigator:
          • Omer Trivizki, MD
  • Italy
    • Milano
      • Milan, Milano, Italy, 20123
        • Recruiting
        • Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe
        • Contact:
        • Principal Investigator:
          • Stela Vujosevic, MD
      • Milan, Milano, Italy, 20132
        • Recruiting
        • Unità di Oculistica, IRCCS Ospedale San Raffaele
        • Contact:
        • Principal Investigator:
          • Francesco Bandello, MD
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Retina-Vitreous Associates Medical Group
        • Principal Investigator:
          • David Boyer, MD
        • Contact:
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Bay Area Retina Associates
        • Principal Investigator:
          • Roger Goldberg, MD
        • Contact:
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Cumberland Valley Retina Consultants
        • Contact:
        • Principal Investigator:
          • David Warrow, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GAL-101 ophthalmic solution
Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
Drug: GAL-101
Patient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
Placebo Comparator: Placebo
Patient will apply daily 2 eye drops ofPlacebo at 5 minutes interval
Drug: Placebo
Patient will apply daily 2 eye drops of Placebo at 5 minutes interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size.
Time Frame: From baseline to last on-treatment visit (48 up to 96 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in photoreceptor degeneration (PRD) in eyes with GA
Time Frame: From baseline to last on-treatment visit (48 up to 96 weeks)
Comparison between groups of annual rate of change in the area of PRD as measured by optical coherence tomography (OCT)
From baseline to last on-treatment visit (48 up to 96 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galimedix Therapeutics Inc

Collaborators

Lexitas Pharma Services, Inc.

Investigators

  • Study Chair: Hermann Russ, MD, PhD, Galimedix Therapeutics Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAL-101-C0201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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