NCT07594236RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
A Phase I Single-Center Open-label Study of C.001 in Patients With Significant Retinal Pigment Epithelium Mediated Maculopathy (RMM)
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 17 Apr 2026
- Start date
- 7 Apr 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Cellio Therapeutics Inc
- Diseases
- Macular degeneration
- NCT number
- NCT07594236
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 15
- From 7 Apr 2026 to the primary completion date, 31 Dec 2028
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active or prior choroidal neovascularization (CNV)
- Recent intraocular surgery within protocol-defined timeframe
- Participation in another investigational study within 3 months prior to screening
Other illness
- Recent myocardial infarction or significant uncontrolled cardiovascular disease
- Significant ocular inflammatory disease
- Active systemic infection
Lab values
- Poorly controlled diabetes (e.g., HbA1c \>8.5%)
Other
- Uncontrolled glaucoma
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Retina Vision Consultants Coordinator of this site? Confirm its status | Beverly Hills | United States | Recruiting |
| Palo Alto Medical Foundation Coordinator of this site? Confirm its status | Palo Alto | United States | Not yet recruiting |
| Retinal Consultants Medical Group Coordinator of this site? Confirm its status | Sacramento | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.