Safety of C.001 injection for retinal pigment epithelium related macular disease
Tests the safety of C.001, injected under the retina, in adults with macular degeneration.
Plain-language title generated from the registry record
Registry title: Phase 1 Study of C.001 in Retinal Degeneration
Key facts
- Where
- Beverly Hills, Palo Alto, and Sacramento, United StatesSee the 3 sites
- Phase
- Phase 1
Where in United States
- Retina Vision ConsultantsBeverly Hills, United StatesTaking people
- Palo Alto Medical FoundationPalo Alto, United StatesNot yet recruiting
- Retinal Consultants Medical GroupSacramento, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cellio Therapeutics Inc
- Trial code
- NCT07594236
- Record updated
- 3 November 2026
- Original description
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.Read full original descriptionShow less
A Phase I Single-Center Open-label Study of C.001 in Patients With Significant Retinal Pigment Epithelium Mediated Maculopathy (RMM)
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.
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 intraocular surgery within protocol-defined timeframe; Participation in another investigational study within 3 months prior to screening; Recent myocardial infarction or significant uncontrolled cardiovascular disease; Significant ocular inflammatory disease; Active systemic infection; Poorly controlled diabetes (e.g., HbA1c >8.5%); Uncontrolled glaucoma.