RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-10

Study Completion:2027-05-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06659549

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.

Ages Eligible for Study:55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	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 13. BCVA of \<5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent) 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

Inclusion Criteria

Exclusion 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

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
13. BCVA of \<5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent)
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

Contacts and Locations

Study Contact

Yaniv Barkana, MD

CONTACT

+972509244044

ybarkana@galimedix.com

Luciana Summo, PhD

CONTACT

lsummo@galimedix.com

Principal Investigator

Hermann Russ, MD, PhD

STUDY_CHAIR

Galimedix Therapeutics Inc

Study Locations (Sites)

Speciality Retina Center, Dr. Shailesh Gupta

Deerfield Beach, Florida, 33064

United States

Collaborators and Investigators

Sponsor: Galimedix Therapeutics Inc

Hermann Russ, MD, PhD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2025-01-10

Study Completion Date2027-05-30

Study Record Updates

Study Start Date2025-01-10

Study Completion Date2027-05-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Geographic Atrophy of the Macula