Trials / Active Not Recruiting
Active Not RecruitingNCT07054632
Efficacy and Safety of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
Efficacy and Safety of Gene Therapy rAAV-RPE65 (LX101) in Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy: a Phase III, Multicenter, Randomized Controlled Trial (STAR)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Innostellar Biotherapeutics Co.,Ltd · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the efficacy and safety of LX101 in subjects with biallelic RPE65 mutation-associated inherited retinal dystrophy. This is an open-label, multicenter, randomized controlled Phase III clinical trial. Subjects were randomly assigned in a 1:1 ratio to either the intervention group or the control group. Subjects in the intervention group received subretinal injection of LX101, while those in the control group received no treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | LX101 | Subretinal administration of LX101 to the study eye |
Timeline
- Start date
- 2023-09-13
- Primary completion
- 2025-08-13
- Completion
- 2029-08-01
- First posted
- 2025-07-08
- Last updated
- 2026-03-05
Locations
4 sites across 1 country: China
Source: ClinicalTrials.gov record NCT07054632. Inclusion in this directory is not an endorsement.