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
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
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)
- Mean change from baseline in Best Corrected Visual Acuity (BCVA) — 36 weeks
BCVA measured by ETDRS
Trial sites (11)
| Facility | City | Region | Status |
|---|---|---|---|
| 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
Safety and Tolerability of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
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LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
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Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy
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Efficacy and Safety of LX101 for Inherited Retinal Dystrophy Associated With RPE65 Mutations
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Other trials for the same condition
TAB014 Compared to Lucentis® in Patients with Neovascular Age-related Macular Degeneration
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LX102 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
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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