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
- Conditions
- Non-foveal geographic atrophy secondary to non-neovascular age-related macular degeneration
- Registration Number
- 2024-519128-26-00
- Lead Sponsor
- Galimedix Therapeutics Inc.
- Brief Summary
Evaluate the efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size
- 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.
Recruitment & Eligibility
- Status
- Authorised, recruiting
- Sex
- Not specified
- Target Recruitment
- 20
= 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 opinion of the Investigator. Criterion will be confirmed at Baseline
Willing and capable of completing MP testing of the study eye in the opinion of the Investigator and verified by the reading center
Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as 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 >= 1.25 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 lesions must be >= 300 µm from the optic disc and/or peripapillary atrophy; g. Area of PRD must be cumulatively between 5.0 and 25.0 mm2
(Study Eye) Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline.
(Study Eye) Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a or planned use during the study period
- 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, and the treatment is not expected to change during the study period. Combination therapy using a single bottle is allowed c) Artificial tears 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
(Study Eye) Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period.
(Non-study Eye) BCVA of < 5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent)
(Either Eye) History of uveitis
(Either Eye) GA Secondary to any condition other than non-neovascular AMD
(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.
(Either Eye) Underwent investigational treatment for AMD within 6 months before Visit 1a.
(General Exclusion Criteria) History of therapeutic radiation to the cranium.
(General Exclusion Criteria) Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients.
(Study Eye) History of laser therapy in the macular region, regardless of indication.
(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).
(General Exclusion Criteria) Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period.
(General Exclusion Criteria) Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period.
(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.
(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.
(General Exclusion Criteria) Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation.
(General Exclusion Criteria) Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline.
(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.
(Study Eye) History of herpes zoster.
(Study Eye) Ophthalmic disease or condition that requires or is likely to require surgery during the study period.
(Study Eye) GA with cumulative area < 1.25 mm2
(Study Eye) Any GA lesion within 100 µm radius from the center point of the fovea.
(Study Eye) Axial length > 26 mm
(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, etc.)
(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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) 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 Outcome Measures
Name Time Method 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) 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)
Comparision between groups of annual rate of change in mean sensitivity of grid points using mesopic microperimetry (MP) (Baseline to last on-treatment visit) Comparision between groups of annual rate of change in mean sensitivity of grid points using mesopic microperimetry (MP) (Baseline to last on-treatment visit)
Trial Locations
- Locations (1)
Institute Of Eye Surgery Limited
🇮🇪Waterford, Ireland
Institute Of Eye Surgery Limited🇮🇪Waterford, IrelandMaged HabibSite contact+35351552050maged@ioes.ie