NCT03197870

The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)

Phase 2 Double-Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of Subcutaneously Administered AKB-9778 (Razuprotafib)15mg Once Daily or 15mg Twice Daily for 12 Months in Patients With Moderate to Severe Non-Proliferative Diabetic Retinopathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: EyePoint Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of subcutaneously administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR).

Conditions

• Nonproliferative Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	AKB-9778	Subcutaneous AKB-9778 15mg
DRUG	Placebo	Subcutaneous Placebo

Timeline

• Start date: 2017-06-09
• Primary completion: 2019-01-09
• Completion: 2019-02-09
• First posted: 2017-06-23
• Last updated: 2023-06-27
• Results posted: 2023-06-27

Locations

53 sites across 1 country: United States

Regulatory

• FDA-regulated drug study