SODIUM (R)-2-(2-AMINO-3-(1H-INDOL-3- YL)PROPANAMIDO)-2-METHYLPROPANOATE-PROPAN-2-OL for Geographic atrophy secondary to non-neovascular age-related macular degeneration (non-foveal)

Inclusion criteria

• {"criterion_text":"- >= 55 years of age"}
• {"criterion_text":"- Willing and able to provide written informed consent"}
• {"criterion_text":"- Willing and able to comply with the study schedule and study assessments"}
• {"criterion_text":"- Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Refractive error between +3 and -6 diopters spherical equivalent in the study eye"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Willing and capable of completing MP testing of the study eye in the opinion of the Investigator and verified by the reading center"}
• {"criterion_text":"- 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

• {"criterion_text":"- (Study Eye) Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline."}
• {"criterion_text":"- (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"}
• {"criterion_text":"- (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"}
• {"criterion_text":"- (Study Eye) Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period."}
• {"criterion_text":"- (Non-study Eye) BCVA of < 5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent)"}
• {"criterion_text":"- (Either Eye) History of uveitis"}
• {"criterion_text":"- (Either Eye) GA Secondary to any condition other than non-neovascular AMD"}
• {"criterion_text":"- (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."}
• {"criterion_text":"- (Either Eye) Underwent investigational treatment for AMD within 6 months before Visit 1a."}
• {"criterion_text":"- (General Exclusion Criteria) History of therapeutic radiation to the cranium."}
• {"criterion_text":"- (General Exclusion Criteria) Known allergy or hypersensitivity to the IMP or any of its excipients."}
• {"criterion_text":"- (Study Eye) History of laser therapy in the macular region, regardless of indication."}
• {"criterion_text":"- (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)."}
• {"criterion_text":"- (General Exclusion Criteria) Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period."}
• {"criterion_text":"- (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"}
• {"criterion_text":"- (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."}
• {"criterion_text":"- (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)"}
• {"criterion_text":"- (General Exclusion Criteria) Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation."}
• {"criterion_text":"- (General Exclusion Criteria) Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline."}
• {"criterion_text":"- (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."}
• {"criterion_text":"- (Study Eye) History of herpes zoster."}
• {"criterion_text":"- (Study Eye) Ophthalmic disease or condition that requires or is likely to require surgery during the study period."}
• {"criterion_text":"- (Study Eye) GA with cumulative area < 1.25 mm2"}
• {"criterion_text":"- (Study Eye) Any GA lesion within 100 µm radius from the center point of the fovea."}
• {"criterion_text":"- (Study Eye) Axial length > 26 mm"}
• {"criterion_text":"- (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.)"}
• {"criterion_text":"- (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."}

Primary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Annual rate of change in GA lesion area measured by fundus autofluorescence (FAF), evaluated from Baseline to last on-treatment visit."}

Secondary endpoints

• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Annual rate of change in PRD area measured by optical coherence tomography (OCT), Baseline to last on-treatment visit."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Annual rate of change in mean sensitivity across specified MP grid points (excluding the 5 points inside the GA lesion and 5 foveal points) using mesopic microperimetry, Baseline to last on-treatment visit."}

Ireland

Earliest CTIS Part Ii Submission Date

03-03-2025

Latest Decision Or Authorization Date

04-04-2025

Processing Time Days

32

Number Of Sites

2

Number Of Participants

20

Germany

Earliest CTIS Part Ii Submission Date

20-08-2025

Latest Decision Or Authorization Date

10-09-2025

Processing Time Days

21

Number Of Sites

7

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

27-08-2025

Latest Decision Or Authorization Date

02-10-2025

Processing Time Days

36

Number Of Sites

3

Number Of Participants

15

France

Earliest CTIS Part Ii Submission Date

08-10-2025

Latest Decision Or Authorization Date

22-10-2025

Processing Time Days

14

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Galimedix Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Merit CRO Inc.

Responsibilities

BCVA, LLVA, Contrast Sensitivity Certification

Name

Catalyst Clinical Research LLC

Responsibilities

8

Name

Lexitas Pharma Services, Inc.

Responsibilities

1,12,5

Name

Imperial Clinical Research Services International Ltd.

Responsibilities

Ancillary Supply Depot

Name

Almac Group Limited

Responsibilities

14

Name

ACM Global Laboratories

Responsibilities

4

Third parties

• {"country":"Germany","full_name":"GRADE Reading Center","duties_or_roles":"Imaging central reading","organisation_type":"Industry"}
• {"country":"Spain","full_name":"Craplatform S.L.","duties_or_roles":"1,12","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Catalyst Clinical Research LLC","duties_or_roles":"8","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Almac Group Limited","duties_or_roles":"14","organisation_type":"Industry"}
• {"country":"United States","full_name":"Imperial Clinical Research Services International Ltd.","duties_or_roles":"Ancillary Supply Depot","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Moorfields Eye Hospital NHS Foundation Trust","duties_or_roles":"Reading Center","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Ace Focused Meetings, LLC","duties_or_roles":"Investigator Meeting Planning","organisation_type":"Industry"}
• {"country":"United States","full_name":"Lexitas Pharma Services, Inc.","duties_or_roles":"1,12,5","organisation_type":"Industry"}
• {"country":"United States","full_name":"ACM Global Laboratories","duties_or_roles":"4","organisation_type":"Industry"}
• {"country":"United States","full_name":"Merit CRO Inc.","duties_or_roles":"BCVA, LLVA, Contrast Sensitivity Certification","organisation_type":"Pharmaceutical company"}
• {"country":"Georgia","full_name":"Across-Medical LTD","duties_or_roles":"1,12","organisation_type":"Industry"}