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OpCT-001

Phase 1

Primary Photoreceptor Disease | Monoclonal antibody | Rare Disease |cbdMD, Inc.|Last Updated: Aug 19, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

OpCT-001 · 1 trial · 9 indications

Phase 1 1
NCT06789445A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)Primary Photoreceptor Disease
RECRUITING54 Analytics
PHASE1RECRUITING
A Study to Investigate the Safety of OpCT-001 in Adults Who Have Primary Photoreceptor Disease (CLARICO)
Primary Photoreceptor Disease
NCT0678944554
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Study Endpoints

Primary Endpoints

Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) through the Week 52 visit
From OpCT-001 administration through the Week 52 visit

Secondary Endpoints

Change from baseline over time through the Week 52 visit in the treated portion of the study eye (SE) retina in outer retinal layer thickness as measured by spectral domain optical coherence tomography (SD-OCT)
From baseline through the Week 52 visit
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1EXPERIMENTALOpCT-001 dose level 1 will be administered via subretinal injection.
Cohort 2EXPERIMENTALOpCT-001 dose level 2 will be administered via subretinal injection.
Cohort 3 (optional)EXPERIMENTALOpCT-001 dose level 3 will be administered via subretinal injection.
Cohort 4EXPERIMENTALOpCT-001 dose level 4 will be administered via subretinal injection.

Interventions

NameTypeDescription
OpCT-001BIOLOGICALCell therapy product composed of photoreceptor precursor cells derived from human induced pluripotent stem cells (iPSCs).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria: * Confirmed genetic diagnosis of primary photoreceptor (PR) disease * Best corrected visual acuity (BCVA) in the study eye at Screening for Phase 1: Logmarithm of the minimum angle of resolution (LogMAR) 3.9 to LogMAR 1.3. BCVA at Screening for Phase 2: ETDRS letter score be...

Countries:United States
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