NCT06212297Active, not recruitingPhase 1/2
Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy
A Clinical Trial to Evaluate the Safety and Efficacy of Subretinal Re-Administration of LX101 to the Contralateral Eye in Subjects With Biallelic RPE65 Mutation-associated Inherited Retinal Dystrophy
Source: ClinicalTrials.gov · Last updated 29 Jun 2025
Brief summary (registry, in English)
Up to nine subjects who have participated in the earlier LX101 clinical study, and who meet all study eligibility criteria, will receive LX101 administration in the previously uninjected, contralateral eye to evaluate the safety of bilateral, sequential subretinal administration of LX101.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 9 (estimated)
- First submitted
- 25 Dec 2023
- Start date
- 12 Sept 2023
- Primary completion date
- 6 Feb 2025
- Lead sponsor
- Innostellar Biotherapeutics Co.,Ltd
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT06212297
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 9
- From 12 Sept 2023 to the primary completion date, 6 Feb 2025
- 1 site 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.
Lab values
- Prior gene therapy except LX101 Active intraocular or periocular infections Lacking of sufficient surviving retinal cells Prior ocular surgery within six months Retinoid like compounds or precursors were taken within three months Complicating systemic diseases Clinically significant abnormal baseline laboratory values Using of any retinal toxic compounds
Who the study is looking for
- Prior subretinal administration of LX101 (unilateral)
- ≥ 6 years old Signed written informed consent
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.