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RO7965032

Phase 2

Geographic Atrophy Secondary to Age-Related Macular Degeneration | Small molecule | Ophthalmology |Roche Holding AG|Last Updated: Oct 1, 2026

Development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Oct 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment321

FDA Designations

No designations recorded

Clinical trial landscape

RO7965032 · 1 trial · 1 indication

Phase 2 1
NCT07851259A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular DegenerationGeographic Atrophy Secondary to Age-Related Macular Degeneration
NOT YET_RECRUITING321 Analytics
PHASE2NOT YET_RECRUITING
A Study to Assess the Efficacy and Safety of RO7965032 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration
Geographic Atrophy Secondary to Age-Related Macular Degeneration
NCT07851259321
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Study Endpoints

Primary Endpoints

Change of GA Lesion Area in the Study Eye
Baseline up to approximately 48 weeks
Incidence and Severity of Ocular Adverse Events (AEs)
Up to approximately 72 Weeks
Incidence and Severity of Non-Ocular AEs
Up to approximately 72 Weeks

Secondary Endpoints

Change of GA Lesion Area in the Study Eye
Baseline up to approximately 72 weeks
Change from Baseline in Best Correct Visual Acuity (BCVA) Score on the Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Baseline up to approximately 48 weeks
Change from Baseline in BCVA Score on the ETDRS Chart Under Low-luminance Conditions
Baseline up to approximately 48 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RO7965032 Dose Level 1EXPERIMENTALParticipants will receive RO7965032.
RO7965032 Dose Level 2EXPERIMENTALParticipants will receive RO7965032.
PlaceboPLACEBO_COMPARATORParticipants will receive placebo.

Interventions

NameTypeDescription
RO7965032DRUGRO7965032 will be administered as per the schedule defined in the protocol.
PlaceboDRUGPlacebo will be administered as per the schedule defined in the protocol.
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: Ocular Inclusion Criteria for the Study Eye * BCVA score of \>= 35 letters using the ETDRS VA chart at a starting distance of 4 meters * Lesions may be either extrafoveal or subfoveal Ocular Inclusion Criteria for Both Eyes * Sufficiently clear ocular media, adequate pupillar...

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Recent Changes (Last 90 Days)

LOWOct 1, 2026NCT07851259NEW_TRIAL: changed
LOWOct 1, 2026NCT07851259NEW_TRIAL: changed

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