NCT05695417

Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

A Phase 1B, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Injection in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Ocular Therapeutix, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Detailed description

Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (axitinib implant) for Intravitreal Injection in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Conditions

• Non-proliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	OTX-TKI	Injection of OTX-TKI
DRUG	Sham	Sham Injection of OTX-TKI

Timeline

• Start date: 2023-01-15
• Primary completion: 2024-01-01
• Completion: 2024-12-01
• First posted: 2023-01-25
• Last updated: 2023-12-08

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study