drugset / Trial / NCT05409235
Nesvategrast (OTT166) in Diabetic Retinopathy (DR)
RandomizedParallel-groupDouble-blindTreatment
Summary
This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.
Timeline
- Start
- 2022-07-29
- Primary completion
- 2023-12-29
- Completion
- 2023-12-29
Outcome
Missed primary endpoint
registry analysis (superiority test); OTT166 Cohort 1 vs Vehicle Control Combined; p = 0.5730; difference in percentage of participants -1.064 (90% CI -10.578 to 8.449) NCT05409235 ↗
registry analysis (superiority test); OTT166 Cohort 2 vs Vehicle Control Combined; p = 0.5750; difference in percentage of participants -1.152 (90% CI -11.178 to 8.874) NCT05409235 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SF0166 | Small molecule | 5 % | Topical |