Clinical trial NCT03197870: The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nonproliferative Diabetic Retinopathy
Lead sponsor: EyePoint Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-06-23
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Key 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)

Key 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

Primary outcomes:
measure: Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps
timeFrame: Baseline to Week 48
Secondary outcomes:
measure: Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48
timeFrame: Baseline to Week 48
measure: Mean Change From Baseline in DRSS in the Study Eye at Week 48
timeFrame: Week 48
measure: Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48.
timeFrame: Baseline to Week 48
measure: 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)
timeFrame: Treatment Period - 12 months (48 weeks)
measure: 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)
timeFrame: Treatment Period - 12 months (48 weeks)
measure: Summary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data.
timeFrame: Treatment Period - 12 months (48 weeks)
measure: Summary of Subjects Developing Center-involved DME or PDR or Worsening of >=2 Steps DRSS at Week 48 Based on Central Image Reading Center Evaluation
timeFrame: Treatment Period - 12 months (48 weeks)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Retina and Vitreous Consultants
state: Arizona
city: Phoenix
country: United States
facility: Retinal Research Institute
state: Arizona
city: Arcadia
country: United States
facility: Retina Institute of California
state: California
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina Vitreous Associates Medical Group
state: California
city: Fullerton
country: United States
facility: Retina Consultants of Orange County
state: California
city: Oceanside
country: United States
facility: Ophthalmic Clinical Trials San Diego
state: California
city: Palo Alto
country: United States
facility: Stanford
state: California
city: Santa Barbara
country: United States
facility: California Retina Consultants
state: California
city: Santa Maria
country: United States
facility: California Retina Consultants
state: California
city: Colorado Springs
country: United States
facility: Retina Consultants of Southern Colorado
state: Colorado
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Lakeland
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Pensacola
country: United States
facility: Retina Specialty Institute
state: Florida
city: Augusta
country: United States
facility: Southeast Retina Center
state: Georgia
city: Marietta
country: United States
facility: Georgia Retina
state: Georgia
city: Oak Forest
country: United States
facility: University Retina
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: West Des Moines
country: United States
facility: Wolfe Eye Clinic
state: Iowa
city: Wichita
country: United States
facility: Central Plains Eye MDs
state: Kansas
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants PC
state: Maryland
city: Boston
country: United States
facility: Opthalmic Consultants of Boston
state: Massachusetts
city: Jackson
country: United States
facility: Specialty Eye Institute
state: Michigan
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Bloomfield
country: United States
facility: Retina Center of New Jersey
state: New Jersey
city: Edison
country: United States
facility: New Jersey Retina
state: New Jersey
city: Northfield
country: United States
facility: Retinal and Ophthalmic Consultants P.C.
state: New Jersey
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: Shirley
country: United States
facility: Island Retina
state: New York
city: Syracuse
country: United States
facility: Retina Vitreous Surgeons of Central New York
state: New York
city: Beachwood
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Middleburg Heights
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Youngstown
country: United States
facility: Retina Associates of Cleveland
state: Ohio
city: Edmond
country: United States
facility: Retina Vitreous Center
state: Oklahoma
city: Bethlehem
country: United States
facility: Mid-Atlantic Retina
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Retina
state: Tennessee
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Austin
country: United States
facility: Retina Research Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Retina Associates
state: Texas
city: Harlingen
country: United States
facility: Valley Retina Institute
state: Texas
city: Houston
country: United States
facility: Retina and Vitreous of Texas
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
Study officials:
References: