Loading clinical trials...

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

COMPLETEDPHASE2

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

NCT03197870•EyePoint Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adults 18 through 80 years of age (inclusive)
•Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive)
•No evidence of central involved diabetic macular edema
•ETDRS best-corrected visual acuity letter score ≥ 70 (Snellen 20/40 or better)

Exclusion Criteria

•Ocular disease other than DR that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, visually significant epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases
•Evidence of neovascularization on clinical examination or imaging
•Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening
•Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation

Locations (53)

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, United States

Retinal Research Institute

Phoenix, Arizona, United States

Retina Institute of California

Arcadia, California, United States

California Retina Consultants

Bakersfield, California, United States

Retina Vitreous Associates Medical Group

Beverly Hills, California, United States

Retina Consultants of Orange County

Fullerton, California, United States

Ophthalmic Clinical Trials San Diego

Oceanside, California, United States

Stanford

Palo Alto, California, United States

California Retina Consultants

Santa Barbara, California, United States

California Retina Consultants

Santa Maria, California, United States

Key Dates

Start Date

June 9, 2017

Primary Completion Date

January 9, 2019

Completion Date

February 9, 2019

Last Updated

June 27, 2023

Enrollment

167

ACTUAL participants

Conditions

Nonproliferative Diabetic Retinopathy

Interventions

AKB-9778

DRUG

Placebo

DRUG

Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)

NCT05383209

Nonproliferative Diabetic Retinopathy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions