Status:
ACTIVE_NOT_RECRUITING
Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
Lead Sponsor:
Innostellar Biotherapeutics Co.,Ltd
Conditions:
Neovascular Age-Related Macular Degeneration
Eligibility:
All Genders
50-89 years
Phase:
PHASE2
Brief Summary
The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.
Detailed Description
In this Phase 2, multi-center, randomized controlled study, subjects will be randomized to receive one of the two dose levels of LX102 (n=20 for each dose level), or aflibercept (n=10). Safety, toler...
Eligibility Criteria
Inclusion
- Willing to sign the informed consent, and willing to attend follow-up visits.
- Age ≥ 50, and ≤ 89.
- Diagnosis of active CNV secondary to neovascular AMD.
- BCVA ETDRS letters between 19 and 73.
- 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.
- Absence of RPE tear at Screening.
- 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 \>8.0%.
Key Trial Info
Start Date :
January 24 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06196840
Start Date
January 24 2024
End Date
October 1 2029
Last Update
August 1 2025
Active Locations (11)
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1
Anhui Provincial Hospital
Hefei, Anhui, China
2
Zhejiang University Eye Hospital
Hangzhou, Zhejiang, China
3
Peking Union Medical College Hospital
Beijing, China
4
West China Hospital of Sichuan University
Chengdu, China