drugset / Trial / NCT03316300
A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol A
Phase 3
Completed
120 enrolled
Neurotech Pharmaceuticals
The Lowy Medical Research Institute Limited · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
This study is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of the NT-501 implants in participants with macular telangiectasia type 2.
Timeline
- Start
- 2017-11-24
- Primary completion
- 2022-08-31
- Completion
- 2022-09-23
Outcome
Met primary endpoint
registry analysis (superiority test); NT-501 vs Sham; p <0.0001; Mean Difference (Final Values) -0.091 (95% CI -0.13 to -0.06); Mixed Models Analysis NCT03316300 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Revakinagene taroretcel | Cell therapy | — | Intravitreal |