Efficacy and Safety of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
NCT ID: NCT07054632
Last Updated: 2025-07-10
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
PHASE3
30 participants
INTERVENTIONAL
2023-09-13
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention group
LX101
Subretinal administration of LX101 to the study eye
Control group
No interventions assigned to this group
Interventions
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LX101
Subretinal administration of LX101 to the study eye
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.
Complicating systemic diseases or clinically significant abnormal baseline laboratory values.
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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Zhongshan Ophthalmic Center, Sun Yat sen University
Guangzhou, Guangdong, China
Southwest Hospital of AMU
Chongqing, , China
Shanghai General Hospital
Shanghai, , China
Tianjin Medical University Ophthalmology Hospital
Tianjin, , China
Countries
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Other Identifiers
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INNOSTELLAR-LX101-1 (phase 2)
Identifier Type: -
Identifier Source: org_study_id
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