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Clinical Trials in China / NCT06196840
Active, not recruiting Phase 2

Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)

NCT06196840 · tracked via the Priya Life Science China tracker
Sponsor
Innostellar Biotherapeutics Co.,Ltd
Phase
Phase 2
Started
2024-01-24
Last updated
2026-03-06

Condition(s) studied

Neovascular Age-Related Macular Degeneration

Investigational drug(s) / intervention(s)

LX102 subretinal injectionAflibercept intravitreal injection

LX102 subretinal injection: LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap

Aflibercept intravitreal injection: Commercially available Active Comparator

Study summary

The goal of this study is to evaluate the overall safety and efficacy of LX102 gene therapy for nAMD.

Eligibility

Sex
ALL
Min age
50 Years
Max age
89 Years
Healthy volunteers
No
Inclusion Criteria: 1. Willing to sign the informed consent, and willing to attend follow-up visits. 2. Age ≥ 50, and ≤ 89. 3. Diagnosis of active CNV secondary to neovascular AMD. 4. BCVA ETDRS letters between 19 and 73. 5. Demonstrated a meaningful response to anti-VEGF therapy. Exclusion Criteria: 1. CNV or macular edema in the study eye secondary to diseases other than nAMD. 2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement. 3. Absence of RPE tear at Screening. 4. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months. 5. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg. 6. Uncontrolled diabetes defined as HbA1c \>8.0%.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Anhui Provincial Hospital Hefei Anhui
Zhejiang University Eye Hospital Hangzhou Zhejiang
Peking Union Medical College Hospital Beijing China
West China Hospital of Sichuan University Chengdu China
Guangzhou Aier Eye Hospital Guangzhou China
Zhongshan Ophthalmic Center of Sun Yat-Sen University Guangzhou China
Shanghai Eye and ENT Hospital Shanghai China
Shanghai General Hospital Shanghai China
Shanxi Eye Hospital Taiyuan China
Tianjin Medical University Eye Hospital Tianjin China
Xuzhou No.1 People's Hospital Xuzhou China

More Innostellar Biotherapeutics Co.,Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06196840 on ClinicalTrials.gov ↗ ← All trials in China