Trials / Active Not Recruiting
Active Not RecruitingNCT06196840
Safety and Efficacy of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
A Phase 2, Randomized Controlled, Open-Label Study to Establish the Safety and Efficacy of LX102 in Patients With Neovascular Age-related Macular Degeneration (nAMD) (VENUS)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- Sponsor
- Innostellar Biotherapeutics Co.,Ltd · Industry
- Sex
- All
- Age
- 50 Years – 89 Years
- Healthy volunteers
- Not accepted
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, tolerability, and efficacy will be evaluated for a period of approximately 1 year from baseline.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | LX102 subretinal injection | LX102: AAV-based gene therapy comprised of codon-optimized sequence encoding VEGF-trap |
| BIOLOGICAL | Aflibercept intravitreal injection | Commercially available Active Comparator |
Timeline
- Start date
- 2024-01-24
- Primary completion
- 2025-06-24
- Completion
- 2029-10-01
- First posted
- 2024-01-09
- Last updated
- 2026-03-06
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06196840. Inclusion in this directory is not an endorsement.