Geographic AtrophyStargardt DiseaseRPE-mediated MaculopathyAge Related Macular Degeneration
Investigational drug(s) / intervention(s)
Injection
Injection: C.001 administered once via subretinal injection
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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
Primary outcome measure(s)
Incidence of Ocular and Systemic Adverse Events — 3 months
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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