This is a first-in-human Phase 1 study evaluating the whether it is safe and how hard side effects are to live with 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.
Official registry: https://clinicaltrials.gov/study/NCT07594236 · Cellio Therapeutics Inc · enrollment listed as 15
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are Injection. The registry lists allocation as randomized. This is a first-in-human Phase 1 study evaluating the whether it is safe and how hard side effects are to live with of C.001 in patients with retinal diseases involving degeneration of the retinal pigment epithelium.
They plan to enroll about 15 people at 3 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.
A Phase I Single-Center Open-label Study of C.001 in Patients With Significant Retinal Pigment Epithelium Mediated Maculopathy (RMM)
Interventions: Injection
Primary outcome (registry wording): Incidence of Ocular and Systemic Adverse Events
Clinical Trial Administrator
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Background: \- Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the back of the eye. Doctors cannot safely obtain retinal cells to study these diseases.
NCT01432847 · Official ClinicalTrials.gov record · National Eye Institute (NEI)
Background: \- To understand diseases of the retina and the eye, information is needed about people with and without such diseases. Researchers want to study these people and follow them over time.
NCT01496625 · Official ClinicalTrials.gov record · National Eye Institute (NEI)
This study will measure the long-term whether it is safe and how hard side effects are to live with of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomly assigned in WR42221.
NCT03683251 · Official ClinicalTrials.gov record · Hoffmann-La Roche
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary