drugset / Trial / NCT03319849
A Study to Determine the Safety and Efficacy of NT-501 in Macular Telangiectasia Type 2 - Protocol B
Phase 3
Completed
119 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
- 2018-01-22
- Primary completion
- 2022-08-31
- Completion
- 2022-09-23
Outcome
Met primary endpoint
registry analysis (superiority test); NT-501 vs Sham; p = 0.0186; Median Difference (Final Values) -0.049 (95% CI -0.0890 to -0.0082); Mixed Models Analysis NCT03319849 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Revakinagene taroretcel | Cell therapy | — | Intravitreal |