drugset / Trial / NCT03630315

CLN-0046: Treatment of AMD Subjects With OTX-TKI

NCT03630315 ↗

Phase 1 Completed 29 enrolled Ocular Therapeutix, Inc.
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

EvaluationDrugModalityDoseRoute
Subject OTX-TKI Small molecule — Intravitreal
Background Aflibercept Protein / enzyme biologic — —
Background Bevacizumab Monoclonal antibody — —
Background Ranibizumab Monoclonal antibody — —