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GAL-101

Phase 2

Geographic Atrophy of the Macula | Small molecule | Other |cbdMD, Inc.|Last Updated: Aug 20, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

GAL-101 · 1 trial · 1 indication

Phase 2 1
NCT06659549A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMDGeographic Atrophy of the Macula
RECRUITING110 Analytics
PHASE2RECRUITING
A Phase 2 Efficacy and Safety Study of GAL-101, 2% Ophthalmic Solution in Non-foveal Geographic Atrophy Secondary to Non-neovascular AMD
Geographic Atrophy of the Macula
NCT06659549110
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Study Endpoints

Primary Endpoints

Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in GA lesion size.
From baseline to last on-treatment visit (48 up to 96 weeks)

Comparison between groups of annual rate of change in the area of GA as measured by fundus autofluorescence (FAF).

Secondary Endpoints

Efficacy of GAL-101 ophthalmic solution in reducing the rate of change in photoreceptor degeneration (PRD) in eyes with GA
From baseline to last on-treatment visit (48 up to 96 weeks)
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
GAL-101 ophthalmic solutionEXPERIMENTALPatient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
PlaceboPLACEBO_COMPARATORPatient will apply daily 2 eye drops ofPlacebo at 5 minutes interval

Interventions

NameTypeDescription
GAL-101DRUGPatient will apply daily 2 eye drops of GAL-101 at 5 minutes interval
PlaceboDRUGPatient will apply daily 2 eye drops of Placebo at 5 minutes interval
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Eligibility Criteria

Age Range55 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion 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 profession...

Countries:United StatesArmeniaFranceGeorgiaGermanyIrelandIsraelItaly
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