Safety and Tolerability of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
NCT ID: NCT06196827
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2022-07-02
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LX101 Dose 1
LX101
Subretinal Administration
LX101 Dose 2
LX101
Subretinal Administration
Interventions
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LX101
Subretinal Administration
Eligibility Criteria
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Inclusion Criteria
Diagnosed with biallelic RPE65 mutation-associated inherited retinal dystrophy.
Subjects are 6 years of age or older.
Visual acuity of ≤ 20/63 or visual field less than 20 degrees in the eye to be injected.
Exclusion Criteria
Pre-existing eye conditions that would interfere with interpretation of study endpoints.
Active intraocular or periocular infections in the study eye.
Lacking of sufficient surviving retinal cells.
Prior ocular surgery within six months.
Complicating systemic diseases or clinically significant abnormal baseline laboratory values.
Pre-existing systemic diseases that should not discontinue the use of any retinal toxic compounds.
6 Years
ALL
No
Sponsors
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Innostellar Biotherapeutics Co.,Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing Tongren Hospital, Capital Medical University
Beijing, , China
Shanghai General Hospital
Shanghai, , China
Countries
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Other Identifiers
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INNOSTELLAR-LX101-1 (phase 1)
Identifier Type: -
Identifier Source: org_study_id
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