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

NCT03197870 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: AKB-9778-CI-5001
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 53

Brief 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

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps

  Change from baseline to Week 48 in Diabetic Retinopathy Severity Scale Score in Study Eye by visit in the modified intent-to-treat population. ETDRS DR severity levels 10-85; ETDRS Steps 1-12

  Baseline to Week 48

Secondary Outcomes (7)

• Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48

  Baseline to Week 48

• Mean Change From Baseline in DRSS in the Study Eye at Week 48

  Week 48

• Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48.

  Baseline to Week 48

• Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Person Scale for Patients With Qualified Fellow Eyes)

  Treatment Period - 12 months (48 weeks)

• Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes)

  Treatment Period - 12 months (48 weeks)

Study Arms (3)

AKB-9778 15mg Daily

EXPERIMENTAL

AKB-9778 15 mg (QD); To maintain masking, subjects will receive BID dosing with masked study medication administered as one dose of active and one dose of matching placebo

Drug: AKB-9778; Drug: Placebo

AKB-9778 15mg Twice Daily

EXPERIMENTAL

AKB-9778 15 mg (BID)

Drug: AKB-9778

Placebo Twice Daily

PLACEBO COMPARATOR

Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID)

Drug: Placebo

Interventions

AKB-9778 DRUG

Subcutaneous AKB-9778 15mg

AKB-9778 15mg Daily; AKB-9778 15mg Twice Daily

Placebo DRUG

Subcutaneous Placebo

AKB-9778 15mg Daily; Placebo Twice Daily

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• EyePoint Pharmaceuticals, Inc.: lead

Study Sites (53)

Arizona Retina and Vitreous Consultants

Phoenix, Arizona, 85021, United States

Location

Retinal Research Institute

Phoenix, Arizona, 85053, United States

Location

Retina Institute of California

Arcadia, California, 91007, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Retina Consultants of Orange County

Fullerton, California, 92835, United States

Location

Ophthalmic Clinical Trials San Diego

Oceanside, California, 92056, United States

Location

Stanford

Palo Alto, California, 94303, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

California Retina Consultants

Santa Maria, California, 93454, United States

Location

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, 80909, United States

Location

Colorado Retina Associates

Golden, Colorado, 80401, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

Center for Retina and Macular Disease

Lakeland, Florida, 33805, United States

Location

Retina Specialty Institute

Pensacola, Florida, 32503, United States

Location

Southeast Retina Center

Augusta, Georgia, 30909, United States

Location

Georgia Retina

Marietta, Georgia, 30060, United States

Location

University Retina

Oak Forest, Illinois, 60452, United States

Location

Illinois Retina Associates

Oak Park, Illinois, 60304, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Wolfe Eye Clinic

West Des Moines, Iowa, 50266, United States

Location

Central Plains Eye MDs

Wichita, Kansas, 67226, United States

Location

Retina Associates of Kentucky

Lexington, Kentucky, 40509, United States

Location

Johns Hopkins University School of Medicine

Baltimore, Maryland, 212876, United States

Location

Cumberland Valley Retina Consultants PC

Hagerstown, Maryland, 21740, United States

Location

Opthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Specialty Eye Institute

Jackson, Michigan, 49202, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Retina Center of New Jersey

Bloomfield, New Jersey, 07003, United States

Location

New Jersey Retina

Edison, New Jersey, 08820, United States

Location

Retinal and Ophthalmic Consultants P.C.

Northfield, New Jersey, 08225, United States

Location

Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Island Retina

Shirley, New York, 11967, United States

Location

Retina Vitreous Surgeons of Central New York

Syracuse, New York, 13224, United States

Location

Retina Associates of Cleveland

Beachwood, Ohio, 44122, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Retina Associates of Cleveland

Middleburg Heights, Ohio, 44130, United States

Location

Retina Associates of Cleveland

Youngstown, Ohio, 44505, United States

Location

Retina Vitreous Center

Edmond, Oklahoma, 73013, United States

Location

Mid-Atlantic Retina

Bethlehem, Pennsylvania, 18017, United States

Location

Tennessee Retina

Nashville, Tennessee, 37203, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Research Center

Austin, Texas, 78705, United States

Location

Texas Retina Associates

Fort Worth, Texas, 76104, United States

Location

Valley Retina Institute

Harlingen, Texas, 78550, United States

Location

Retina and Vitreous of Texas

Houston, Texas, 77025, United States

Location

Retina Consultants of Houston

Houston, Texas, 77030, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Houston

The Woodlands, Texas, 77384, United States

Location

Spokane Eye Clinical Research

Spokane, Washington, 99204, United States

Location

MeSH Terms

Interventions

AKB-9778

Results Point of Contact

• Title: David Bauer
• Organization: EyePoint Pharmaceuticals, Inc

dbauer@eyepointpharma.com

8573410747

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2017
• First Posted: June 23, 2017
• Study Start: June 9, 2017
• Primary Completion: January 9, 2019
• Study Completion: February 9, 2019
• Last Updated: June 27, 2023
• Results First Posted: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (53)