Trials / Active Not Recruiting
Active Not RecruitingNCT05099094
VEGFA-targeting Gene Therapy to Treat Retinal and Choroidal Neovascularization Diseases
A Safety and Efficacy Study of VEGFA-targeting Gene Therapy to Treat Refractory Retinal and Choroidal Neovascularization Diseases
- Status
- Active Not Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Shanghai BDgene Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Patients who respond to anti-VEGF therapy but with refractory retinal and choroidal neovascularization diseases including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion-Macular edema (RVO-ME).
Detailed description
Choroidal and retinal angiogenesis diseases are a group of diseases characterized by choroidal or retinal angiogenesis. These diseases are often correlated with the macular area, which may lead to significant visual loss. In this study, The IDLV vector is engineered to carry the VEGFA antibody gene. The gene is delivered to the RPE cells to express the VEGFA antibody which neutralizes the VEGFA activity in the posterior segment of the eye of individuals who have progressed to various forms of neovascular macular degeneration.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | BD311 | Integration-deficient lentiviral vector (IDLV) expressing VEGFA antibody |
Timeline
- Start date
- 2021-11-25
- Primary completion
- 2024-11-30
- Completion
- 2025-09-01
- First posted
- 2021-10-29
- Last updated
- 2025-05-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05099094. Inclusion in this directory is not an endorsement.