NCT05409235

Nesvategrast (OTT166) in Diabetic Retinopathy (DR)

OTT166-201 A Phase 2 Randomized, Double-Masked, Vehicle-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of OTT166 Ophthalmic Solution in the Treatment of Diabetic Retinopathy (DR)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: OcuTerra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 2:2:1:1 into the following groups: OTT166 5% twice daily (BID), OTT166 5% four times daily (QID), vehicle control BID, vehicle control QID. Randomization will be stratified by baseline Diabetic Retinopathy Severity Scale (DRSS) score (47 or 53 or 61B). Participants with PDR (DRSS score 61B) will be capped at 20% of all randomized participants. Each group will self-administer one 50-μl eye drop of study solution (frequency as assigned) for 24 weeks.

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	OTT166	Participants will receive OTT166 ophthalmic solution
DRUG	Vehicle control	Participants will receive vehicle control

Timeline

• Start date: 2022-07-29
• Primary completion: 2023-12-29
• Completion: 2023-12-29
• First posted: 2022-06-08
• Last updated: 2024-08-09
• Results posted: 2024-08-09

Locations

68 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study