Phase 1 Study of C.001 in Retinal Degeneration

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Cellio Therapeutics Inc
Study ID
NCT07594236
Phase
PHASE1
Status
Recruiting
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Conditions

  • Age Related Macular Degeneration
  • Geographic Atrophy
  • RPE-mediated Maculopathy
  • Stargardt Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Injection — BIOLOGICAL
    C.001 administered once via subretinal injection

Study Details

This is a first-in-human Phase 1 study evaluating the safety and tolerability of C.001 in patients with retinal diseases involving degeneration of the retinal pigment epithelium. Participants will receive a single administration of C.001 delivered by subretinal injection. The study will evaluate three dose levels in a sequential manner. The primary objective is to assess the safety of C.001 over a 3-month period following administration. Participants will be followed for up to 12 months to further evaluate safety and explore changes in visual function and retinal structure.

Key Dates

Start date
Apr 7, 2026
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    C.001Low Dose
  • Experimental: Arm 2
    C.001 Medium Dose
  • Experimental: Arm 3
    C.001 High Dose

Primary Outcome Measure

Incidence of Ocular and Systemic Adverse Events [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Trial Site 1Beverly HillsCalifornia90210
Clinical Trial Administer
[email protected]
302-588-2013

Find similar trials in Beverly Hills, CA

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Clinical Trial· Beverly Hills, CA

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