Nesvategrast (OTT166) in Diabetic Retinopathy (DR)

Status Completed

Clinical Trial Summary

This study will evaluate the safety and efficacy of OTT166 Ophthalmic solution in participants with Diabetic Retinopathy.

Clinical Trial Description

This randomized, double-masked, vehicle controlled, phase 2 study will evaluate the safety and efficacy of OTT166 ophthalmic solution in participants with diabetic retinopathy and select an optimum dosing regimen for Phase 3 pivotal trials. Approximately 210 participants diagnosed with moderately severe to severe non-proliferative diabetic retinopathy (NPDR) or mild proliferative diabetic retinopathy (PDR) and who are treatment naïve (ie, no prior anti-vascular endothelial growth factor [anti-VEGF] or laser [focal, grid, pan-retinal photocoagulation (PRP)] administered) will be randomized into the following groups: OTT166 Cohort 1, OTT166 Cohort 2, Vehicle control Cohort 1, Vehicle control Cohort 2. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05409235
Study type	Interventional
Source	OcuTerra Therapeutics, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	July 29, 2022
Completion date	December 29, 2023

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