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Tests treatment safety and results for Geographic Atrophy of the Macula
Official title A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
ClinicalTrials.gov ID: NCT06659549
What this study is testing
What is GAL-101?
GAL-101 is an investigational medicine, given as an once-daily, being studied as a potential treatment for geographic atrophy of the macula.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Age-related macular degeneration (AMD) affects millions of elderly patients. When advanced, there is Geographic Atrophy (GA) in the retina.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- ≥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...
- BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will...
You likely can't join if
- Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline
- History of laser therapy in the macular region, regardless of indication
- History of herpes zoster
- Ophthalmic disease or condition that requires or is likely to require surgery during the study period
- GA with cumulative area \<1.25 mm2
- Any GA lesion within 100 µm radius from the center point of the fovea
See the full eligibility 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
- Well-delineated cumulative GA area between 1.25 and 12.0 mm2
- If GA is multifocal, at least 1 lesion ≥1.25 mm2
- 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)
- GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea
- 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
- GA lesions must be \>300 µm from the optic disc and/or peripapillary atrophy
- Area of PRD must be cumulatively between 7.25 and 25.0 mm2
- Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline
- History of laser therapy in the macular region, regardless of indication
- History of herpes zoster
- Ophthalmic disease or condition that requires or is likely to require surgery during the study period
- GA with cumulative area \<1.25 mm2
- Any GA lesion within 100 µm radius from the center point of the fovea
- Axial length \>26 mm
- 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...
- 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...
- 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
- 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
- GA secondary to any condition other than non-neovascular AMD
- History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline
- Underwent investigational treatment for AMD within 6 months before Visit 1a General Exclusion Criteria:
- History of therapeutic radiation to the cranium
- Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients
- History of malignant disease
- Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period
- Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period
- 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
- 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
- Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation
- Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Walnut Creek, California, United States
- Hagerstown, Maryland, United States
- Yerevan, Armenia
- Marseille, France
- Tbilisi, Georgia
- Bonn, Germany
- Waterford, Ireland
- Jerusalem, Israel
- Tel Aviv, Israel
- Milan, Milano, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Walnut Creek, California, United States; Hagerstown, Maryland, United States; Yerevan, Armenia; Marseille, France; Tbilisi, Georgia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.