Actively Recruiting

Early Phase 1
Age: 4Years +
All Genders
NCT07063030

A Study of LX107 Gene Therapy in AIPL1-IRD Patients

Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2026-03-10

13

Participants Needed

1

Research Sites

285 weeks

Total Duration

On this page

Sponsors

S

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Lead Sponsor

I

Innostellar Biotherapeutics Co.,Ltd

Collaborating Sponsor

AI-Summary

What this Trial Is About

Administering subretinal injection of LX107 injection (a gene therapy drug) to patients with retinal dystrophy caused by AIPL1 gene mutation to evaluate its efficacy and safety.

CONDITIONS

Official Title

A Study of LX107 Gene Therapy in AIPL1-IRD Patients

Who Can Participate

Age: 4Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • The participant or guardian signs informed consent and agrees to long-term follow-up
  • Age 4 years or older, adult or pediatric patients
  • Confirmed diagnosis of inherited retinal dystrophy caused by biallelic AIPL1 gene mutations
  • The study eye has a best-corrected visual acuity of no more than 58 letters (about 0.3 decimal) on the ETDRS chart at baseline
Not Eligible

You will not qualify if you...

  • History of eye diseases that could interfere with treatment or study results (e.g., glaucoma, diabetic retinopathy, retinal vein occlusion, retinal detachment, uveitis)
  • Previous gene therapy for inherited retinal dystrophy or related hereditary eye diseases
  • Insufficient viable retinal cells in the study eye
  • Active infection in or around the study eye
  • History of intraocular surgery within 6 months before screening
  • Uncontrolled high blood pressure (systolic 60 160 mmHg or diastolic 60 100 mmHg)
  • Diabetes with macrovascular complications, HbA1c over 7.5%, or treatment with multiple diabetes medications
  • Other diseases or conditions judged by the investigator to pose risks or interfere with study participation
  • Certain lab abnormalities including low platelet count, low hemoglobin, high liver enzymes, or impaired kidney function
  • Use of other investigational drugs within 3 months before screening
  • Unwillingness to use contraception or pregnancy/lactation during the study period

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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