Status:
ACTIVE_NOT_RECRUITING
LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
Lead Sponsor:
Innostellar Biotherapeutics Co.,Ltd
Conditions:
Neovascular Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
The goal of this study is to evaluate the safety and efficacy of LX102 gene therapy for nAMD.
Detailed Description
This study will enroll subjects aged ≥ 50 years old to receive a single unilateral subretinal injection of LX102 to evaluate its safety and efficacy.
Eligibility Criteria
Inclusion
- Willing to sign the informed consent, and willing to attend follow-up visits.
- Age ≥ 50
- Diagnosis of active CNV secondary to neovascular AMD
- BCVA ETDRS letters between 5 and 63
- Subjects must have received a minimum of 2 injections within 6 months prior to screening
- Demonstrated a meaningful response to anti-VEGF therapy
Exclusion
- CNV or macular edema in the study eye secondary to diseases other than nAMD
- Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement
- Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
- Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
- Uncontrolled diabetes defined as HbA1c \>7.5%
Key Trial Info
Start Date :
February 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2029
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06198413
Start Date
February 27 2023
End Date
January 1 2029
Last Update
July 1 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Anhui Provincial Hospital
Hefei, Anhui, China
2
Zhejiang University Eye Hospital
Hangzhou, Zhejiang, China
3
Shanghai General Hospital
Shanghai, China