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Clinical Trials in the USA / NCT07594236
Recruiting Phase 1

Phase 1 Study of C.001 in Retinal Degeneration

NCT07594236 · tracked via the Priya Life Science USA tracker
Sponsor
Cellio Therapeutics Inc
Phase
Phase 1
Started
2026-04-07
Last updated
2026-08-17

Condition(s) studied

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

Trial sites (3)

FacilityCityRegionStatus
Retina Vision Consultants Beverly Hills California Recruiting
Palo Alto Medical Foundation Palo Alto California Not Yet Recruiting
Retinal Consultants Medical Group Sacramento California Not Yet Recruiting

Other trials for the same condition

Stem Cell Ophthalmology Treatment Study II Recruiting
An Observational Study in Subjects to Follow the Progression of Stargardt Disease Type 1 (STGD1) Caused by Bi-Allelic Autosomal Recessive Mutations in the ABCA4 Gene Recruiting
A Prospective, Multicenter, Open-Label, Observational Phase 4 Study to Evaluate Real-World Safety, Tolerability, and Treatment Patterns of Pegcetacoplan (Syfovre) in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Active, not recruiting
Development and Evaluation of Functional Visual Field and Navigation Endpoints in Moderate to Profound Inherited Retinal Disease (DEFINE-IRD) Recruiting
A Phase 2/3 Trial to Assess the Efficacy and Safety of OCU410ST for Stargardt Disease Active, not recruiting
Official registry record

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.

View NCT07594236 on ClinicalTrials.gov ↗ ← All trials in the USA