Trials / Recruiting
RecruitingNCT06749639
Safety and Efficacy Study of PUMCH-E101 Injection in Subjects with RDH12 Retinopathy
An Open-Label, Single-Center, Dose-Escalation Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Intravitreal Injection of PUMCH-E101 in Subjects with RDH12 Retinopathy
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Peking Union Medical College Hospital · Academic / Other
- Sex
- All
- Age
- 8 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this clinical trial is to evaluate the safety and efficacy of PUMCH-E101 injection in subjects with RDH12 retinopathy.
Detailed description
This is an open-label, single-center, dose-escalation study. One eye of each participant will receive a single intravitreal injection of PUMCH-E101. Participants will be followed for 52 weeks after which they will continue to be followed for up to 5 years after enrollment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | PUMCH-E101 Injection（Low dose） | Single intravitreal injection |
| GENETIC | PUMCH-E101 Injection（High dose） | Single intravitreal injection |
Timeline
- Start date
- 2024-09-20
- Primary completion
- 2027-12-31
- Completion
- 2030-01-04
- First posted
- 2024-12-27
- Last updated
- 2024-12-31
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06749639. Inclusion in this directory is not an endorsement.