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ONL1204 Opthalmic

Phase 2

Geographic Atrophy (GA) | Small molecule | Ophthalmology |cbdMD, Inc.|Last Updated: Aug 26, 2026

Target and mechanism

ModalitySmall molecule

Also known as ONL1204 Opthalmic solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment324

FDA Designations

No designations recorded

Clinical trial landscape

ONL1204 Opthalmic · 1 trial · 2 indications

Phase 2 1
NCT06659445Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMDGeographic Atrophy (GA)
RECRUITING324 Analytics
PHASE2RECRUITING
Study to Evaluate Efficacy and Safety of ONL1204 in Patients With GA Associated With AMD
Geographic Atrophy (GA)Unlock trial analytics

Study Endpoints

Primary Endpoints

Primary Endpoint
From enrollment to the end of treatment at 48 weeks.

GA lesion area

Secondary Endpoints

Secondary Endpoints (Safety)
From enrollment to the end of treatment at 48 weeks.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ONL1204 Opthalmic solution (1 of 6 Treatment Groups) administered by intravitreal injectionACTIVE_COMPARATORONL1204 100 µg administered by intravitreal (IVT) injection every 12 weeks
ONL1204 Opthalmic solution (2 of 6 Treatment Groups) administered by intravitreal injectionACTIVE_COMPARATORONL1204 200 µg administered by intravitreal (IVT) injection every 12 weeks
ONL1204 Opthalmic solution (3 of 6 Treatment Groups) administered by intravitreal injectionEXPERIMENTALONL1204 200 µg administered by intravitreal (IVT) injection every 24 weeks
Sham Comparator (4 of 6 Treatment Groups)SHAM_COMPARATORSham injection every 12 weeks
Sham Comparator (5 of 6 Treatment Groups)SHAM_COMPARATORSham injection every 24 weeks
Avacincaptad pegol intravitreal solution (6 of 6 Treatment Groups - US ONLY)ACTIVE_COMPARATORAvacincaptad pegol administered by intravitreal (IVT) injection - (2 mg (0.1 mL of 20 mg/mL solution) once monthly

Interventions

NameTypeDescription
ONL1204 Opthalmic solutionDRUGLiquid formulation ONL1204 Ophthalmic Solution administered by intravitreal (IVT) injection
Avacincaptad Pegol intravitreal solutionDRUGLiquid formulation Avacincaptad Pegol administered by intravitreal (IVT) injection
ShamOTHERSham injection
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Eligibility Criteria

Age Range55 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites117

Inclusion Criteria: 1. 55 years of age or older at Screening. 2. Able and willing to give informed consent and attend study visits. 3. Women or intersex individuals must be willing to use 2 forms of effective contraception during the study and for at least 90 days following the last dose of study d...

Countries:United StatesAustriaCanadaCzechiaGermanyGreeceHungaryPolandPortugalSpainSwitzerlandUnited Kingdom
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Competitive Landscape -Geographic Atrophy 9 trials (matched to "Geographic Atrophy (GA)")