drugset / Trial / NCT05409235

Nesvategrast (OTT166) in Diabetic Retinopathy (DR)

NCT05409235 ↗

Phase 2 Completed 225 enrolled OcuTerra Therapeutics, Inc. Parexel · collab
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

EvaluationDrugModalityDoseRoute
Subject SF0166 Small molecule 5 % Topical

Indications