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

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03660371` - ILM Peeling in PDR Patients Undergoing PPV for VH	N/A
Completed	`NCT03660345` - PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME	Phase 3
Completed	`NCT03660384` - Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy	N/A
Completed	`NCT04905459` - ARDA Software for the Detection of mtmDR
Active, not recruiting	`NCT04271709` - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)	N/A
Recruiting	`NCT03713268` - Intraoperative OCT Guidance of Intraocular Surgery II
Completed	`NCT05022615` - Comparing 3 Imaging Systems
Completed	`NCT00385333` - Metabolic Mapping to Measure Retinal Metabolism	Phase 2
Recruiting	`NCT04101604` - Biomarkers of Common Eye Diseases
Completed	`NCT03702374` - Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy	Phase 3
Completed	`NCT01908816` - An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.	Phase 3
Completed	`NCT04009980` - Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.	N/A
Completed	`NCT02924311` - Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
Not yet recruiting	`NCT06257082` - Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities	N/A
Not yet recruiting	`NCT05452993` - Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography	N/A
Withdrawn	`NCT02812030` - Aflibercept for Retinopathy in the Real World	N/A
Completed	`NCT02391558` - Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography	N/A
Active, not recruiting	`NCT02330042` - OCT Biomarkers for Diabetic Retinopathy
Active, not recruiting	`NCT02353923` - OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy	N/A
Completed	`NCT02390245` - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study	N/A