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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Galimedix Therapeutics Inc.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

22 May 2025 → ongoing

Decision date (initial)

2025-10-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Galimedix Therapeutics, Inc.

External identifiers

EU CT number

2024-519128-26-00

ClinicalTrials.gov

NCT06659549

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

Evaluate the efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size

Secondary objectives 4

1. Evaluate the efficacy of GAL-101 ophthalmic solution in reducing the rate of change in photoreceptor degeneration (PRD) in eyes with GA
2. Evaluate the neuroprotective efficacy of GAL-101 ophthalmic solution in preserving photoreceptors and retinal function.
3. Evaluate the neuroenhancement efficacy of GAL-101 ophthalmic solution in improving visual function.
4. Evaluate the ocular and systemic safety of GAL-101 ophthalmic solution.

Conditions and MedDRA coding

Non-foveal geographic atrophy secondary to non-neovascular age-related macular degeneration

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Icelandic Medicines Agency, Food And Drug Administration

Plan to share IPD

No

IPD plan description

Undecided

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. > = 55 years of age
2. Willing and able to provide written informed consent
3. Willing and able to comply with the study schedule and study assessments
4. Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution.
5. 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.
6. Refractive error between +3 and -6 diopters spherical equivalent in the study eye
7. Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in opinion of the Investigator. Criterion will be confirmed at Baseline
8. Willing and capable of completing MP testing of the study eye in the opinion of the Investigator and verified by the reading center
9. Previously established diagnosis of non-foveal GA secondary to non-neovascular AMD in the study eye. Specific GA lesion criteria will be confirmed by the reading center: a. Well-delineated cumulative GA area between 1.25 and 12.0 mm2; b. If GA is multifocal, at least 1 lesion >= 0.7 mm2; c. 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); d. GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea; e. 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. f. GA lesion(s) are not confluent with the optic disc or peripapillary atrophy (peripapillary atrophy may otherwise be present); g. Area of PRD must be cumulatively between 5.0 and 25.0 mm2

Exclusion criteria 27

1. (Study Eye) Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline.
2. (Study Eye) History of laser therapy in the macular region, regardless of indication.
3. (Study Eye) History of herpes zoster.
4. (Study Eye) Ophthalmic disease or condition that requires or is likely to require surgery during the study period.
5. (Study Eye) GA with cumulative area < 1.25 mm2
6. (Study Eye) Any GA lesion within 100 µm radius from the center point of the fovea.
7. (Study Eye) Axial length > 26 mm
8. (Study Eye) 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, presumed ocular histoplasmosis, etc.)
9. (Study Eye) 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. (Study Eye) Use of any pharmacologic (e.g., pegcetacoplan or avacincaptad pegol) or device (e.g., photobiomodulation) intervention intended for the treatment of non-neovascular AMD or other macular disease within 6 months before Visit 1a, or planned use during the study period
11. (Study Eye) Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period Note: a) Ophthalmic solutions used during study assessments are exempt and allowed b) Intraocular pressure (IOP)-lowering therapies are exempt and allowed if patient’s IOP is well controlled, in the Investigator’s opinion, using a single bottle, the treatment has been stable for >3 months, IOP is ≤26 mmHg at Visit 1a, and the treatment is not expected to change during the study period. Combination therapy using a single bottle is allowed c) Artificial tears and lifitegrast or cyclosporine eye drops are exempt and allowed d) Approved therapies for non-neovascular age-related macular degeneration are exempt and allowed at any time after randomization e) Approved therapies for neovascular AMD are exempt and allowed at any time after randomization if CNV was newly detected f) For local eye irritation or inflammation, short course ophthalmic treatments containing corticosteroids (i.e., fluoromethalone or loteprednol) are exempt and allowed
12. (Study Eye) Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period.
13. (Non-study Eye) BCVA of < 5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent)
14. (Either Eye) History of uveitis
15. (Either Eye) GA Secondary to any condition other than non-neovascular AMD
16. (Either Eye) History of active ocular infection or inflamation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline. Note: Acute conjunctivitis is only exclusionary within 1 month before Visit 1a or Baseline.
17. (Either Eye) Underwent investigational treatment for AMD within 6 months before Visit 1a.
18. (General Exclusion Criteria) History of therapeutic radiation to the cranium.
19. (General Exclusion Criteria) Known allergy or hypersensitivity to the IMP or any of its excipients.
20. (General Exclusion Criteria) History of malignant disease. Note: Patients with active malignancies, defined as presence of detectable cancer or undergoing treatment for cancer, are not eligible for the study. Note: Patients may be eligible based on their overall health status, as determined by the Investigator in consultation with the Medical Monitor(s) and Sponsor, if they have undergone surgical treatment resulting in pathologically confirmed complete resection of the cancer or are in complete remission with no evidence of cancer, and off all therapies (excluding prophylactic therapies).
21. (General Exclusion Criteria) Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period.
22. (General Exclusion Criteria) Participated in other IMP study or treatment with any other IMP within 1 month or 5 times the half-life of the IMP/relevant metabolites (whichever is longer) before Visit 1a or plan to participate in any other IMP study during the study period
23. (General Exclusion Criteria) 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. (General Exclusion Criteria) 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, or uncontrolled Grade 3 hypertension as defined in 2023 European Society of Hypertension Guidelines (systolic, ≥180 mmHg; diastolic, ≥110 mmHg)
25. (General Exclusion Criteria) Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation.
26. (General Exclusion Criteria) Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline.
27. (General Exclusion Criteria) 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Comparision between groups of annual rate of change in the area of GA as measured by fundus autofluorescence (FAF) (Baseline to last on-treatment visit)

Secondary endpoints 2

1. Comparision between groups of annual rate of change in the area of PRD as measured by optical coherence tomography (OCT) (Baseline to last on-treatment visit)
2. Comparison between groups of annual rate of change in mean sensitivity of all grid points, excluding the 5 points inside the GA lesion and the 5 points fixed in the fovea, using mesopic microperimetry (MP) (Baseline to last on-treatment visit)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Galimedix Therapeutics Inc.

Sponsor organisation

Galimedix Therapeutics Inc.

Address

3704 Calvend Lane

City

Kensington

Postcode

20895-3112

Country

United States

Scientific contact point

Organisation

Galimedix Therapeutics Inc.

Contact name

Chief Scientific Officer

Public contact point

Organisation

Galimedix Therapeutics Inc.

Contact name

Sponsor Information Desk

Third parties 11

Locations

4 EU/EEA countries · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 22 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications