drugset / Trial / NCT03630315
CLN-0046: Treatment of AMD Subjects With OTX-TKI
RandomizedSequentialOpen-labelTreatment
Summary
To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD).
Timeline
- Start
- 2019-02-18
- Primary completion
- 2024-01-10
- Completion
- 2024-01-10
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
release “In the higher-dose cohort, a decrease in intraretinal and/or subretinal fluid was seen in some subjects treated with OTX-TKI as a monotherapy.” ocutx.com ↗
release “This Phase 1 clinical trial is not powered to measure any efficacy endpoints with statistical significance.” ocutx.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OTX-TKI | Small molecule | — | Intravitreal |
| Background | Aflibercept | Protein / enzyme biologic | — | — |
| Background | Bevacizumab | Monoclonal antibody | — | — |
| Background | Ranibizumab | Monoclonal antibody | — | — |