Phase 1 Study of C.001 for Retinal Degeneration

This is a Phase 1 study testing the safety of a new treatment called C.001 for people with certain retinal diseases, like Geographic Atrophy or Stargardt Disease. These conditions involve the degeneration of the retinal pigment epithelium (RPE), a layer of cells in the eye. You would receive a single injection of C.001 directly into your eye (subretinal injection). Researchers want to see if C.001 is safe over 3 months, and they will also watch for changes in your vision and eye structure for up to 12 months. This study is for adults aged 18 and older who meet specific vision and health requirements. The current recruitment status is unclear.

Study design
This is a Phase 1, single-center, open-label study with 15 planned participants. It will test three different dose levels of C.001 sequentially.
What's involved
You would receive a single subretinal injection of C.001. You will have follow-up visits for safety assessments for up to 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 12 months after treatment to assess safety and explore changes in vision and eye structure.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07594236

Phase 1 Study of C.001 in Retinal Degeneration

Recruiting
PHASE1Ages 18+InterventionalTreatment
Cellio Therapeutics Inc
~15 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:Injection

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Ocular and Systemic Adverse Events
Measured over 3 months
Geographic Atrophy
Stargardt Disease
RPE-mediated Maculopathy
Age Related Macular Degeneration
3 sites across 1 states
California3

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Eligibility criteria

Inclusion

Age ≥18 years
Diagnosis of retinal disease associated with retinal pigment epithelium degeneration (e.g., geographic atrophy or Stargardt disease)
Visual acuity within protocol-defined limits
Stable ocular condition prior to enrollment
Medically suitable for ophthalmic surgery and anesthesia
Willingness to comply with study procedures and follow-up

Exclusion

Active or prior choroidal neovascularization (CNV)
Recent myocardial infarction or significant uncontrolled cardiovascular disease
Uncontrolled glaucoma
Significant ocular inflammatory disease
Recent intraocular surgery within protocol-defined timeframe
Active systemic infection
Poorly controlled diabetes (e.g., HbA1c \>8.5%)
Participation in another investigational study within 3 months prior to screening
  • Incidence of Ocular and Systemic Adverse Events3 months