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

Primary Purpose

Nonproliferative Diabetic Retinopathy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AKB-9778
Placebo
Sponsored by
EyePoint Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonproliferative Diabetic Retinopathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 DME
  • ETDRS BCVA 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

Sites / Locations

  • Arizona Retina and Vitreous Consultants
  • Retinal Research Institute
  • Retina Institute of California
  • California Retina Consultants
  • Retina Vitreous Associates Medical Group
  • Retina Consultants of Orange County
  • Ophthalmic Clinical Trials San Diego
  • Stanford
  • California Retina Consultants
  • California Retina Consultants
  • Retina Consultants of Southern Colorado
  • Colorado Retina Associates
  • Rand Eye Institute
  • Center for Retina and Macular Disease
  • Retina Specialty Institute
  • Southeast Retina Center
  • Georgia Retina
  • University Retina
  • Illinois Retina Associates
  • Midwest Eye Institute
  • Wolfe Eye Clinic
  • Central Plains Eye MDs
  • Retina Associates of Kentucky
  • Johns Hopkins University School of Medicine
  • Cumberland Valley Retina Consultants PC
  • Opthalmic Consultants of Boston
  • Specialty Eye Institute
  • Sierra Eye Associates
  • Retina Center of New Jersey
  • New Jersey Retina
  • Retinal and Ophthalmic Consultants P.C.
  • Eye Associates of New Mexico
  • Island Retina
  • Retina Vitreous Surgeons of Central New York
  • Retina Associates of Cleveland
  • Cincinnati Eye Institute
  • Retina Associates of Cleveland
  • Retina Associates of Cleveland
  • Retina Vitreous Center
  • Mid-Atlantic Retina
  • Tennessee Retina
  • Retina Research Institute of Texas
  • Texas Retina Associates
  • Austin Retina Associates
  • Retina Research Center
  • Texas Retina Associates
  • Valley Retina Institute
  • Retina and Vitreous of Texas
  • Retina Consultants of Houston
  • Valley Retina Institute
  • Medical Center Ophthalmology Associates
  • Retina Consultants of Houston
  • Spokane Eye Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

AKB-9778 15mg Daily

AKB-9778 15mg Twice Daily

Placebo Twice Daily

Arm Description

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

AKB-9778 15 mg (BID)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48
Worsening of Diabetic Retinopathy Severity Score (DRSS) severity of ≥ 2 steps in study eyes at Week 48 (compared to placebo group) Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
Mean Change From Baseline in DRSS in the Study Eye at Week 48
Mean change from baseline in Diabetic Retinopathy Severity Score (DRSS) in the study eye at week 48. Note: Observed values at Week 48 instead of change from baseline values at Week 48 were analyzed Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48.
Summary of subjects with an improvement or worsening in the study eye Diabetic Retinopathy Severity Score (DRSS) of ≥ 3 steps at Week 48 (compared to placebo) Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
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)
Subjects with Criterion Step Improvement in Diabetic Retinopathy Severity Score (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). Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
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)
Subjects With Criterion Step Improvement in Diabetic Retinopathy Severity Score (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). Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
Summary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data.
Summary of patients developing center-involved Diabetic Macular Edema (DME) or Proliferative Diabetic Retinopathy (PDR) or PDR-related outcomes during treatment period based on Clinical Data. Based on either clinical data or central image reading center evaluation.
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
Summary of Subjects Developing Center-involved Diabetic Macular Edema (DME) or Proliferative Diabetic Retinopathy (PDR) or Worsening of >=2 Steps Diabetic Retinopathy Severity Scale (DRSS) at Week 48 Based on Central Image Reading Center Evaluation - Study Eyes Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

Full Information

First Posted
June 22, 2017
Last Updated
June 1, 2023
Sponsor
EyePoint Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03197870
Brief Title
The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)
Acronym
TIME-2b
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
January 9, 2019 (Actual)
Study Completion Date
February 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EyePoint Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonproliferative Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AKB-9778 15mg Daily
Arm Type
Experimental
Arm Description
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
Arm Title
AKB-9778 15mg Twice Daily
Arm Type
Experimental
Arm Description
AKB-9778 15 mg (BID)
Arm Title
Placebo Twice Daily
Arm Type
Placebo Comparator
Arm Description
Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID)
Intervention Type
Drug
Intervention Name(s)
AKB-9778
Intervention Description
Subcutaneous AKB-9778 15mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subcutaneous Placebo
Primary Outcome Measure Information:
Title
Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps
Description
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
Time Frame
Baseline to Week 48
Secondary Outcome Measure Information:
Title
Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48
Description
Worsening of Diabetic Retinopathy Severity Score (DRSS) severity of ≥ 2 steps in study eyes at Week 48 (compared to placebo group) Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
Time Frame
Baseline to Week 48
Title
Mean Change From Baseline in DRSS in the Study Eye at Week 48
Description
Mean change from baseline in Diabetic Retinopathy Severity Score (DRSS) in the study eye at week 48. Note: Observed values at Week 48 instead of change from baseline values at Week 48 were analyzed Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
Time Frame
Week 48
Title
Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48.
Description
Summary of subjects with an improvement or worsening in the study eye Diabetic Retinopathy Severity Score (DRSS) of ≥ 3 steps at Week 48 (compared to placebo) Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
Time Frame
Baseline to Week 48
Title
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)
Description
Subjects with Criterion Step Improvement in Diabetic Retinopathy Severity Score (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). Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
Time Frame
Treatment Period - 12 months (48 weeks)
Title
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)
Description
Subjects With Criterion Step Improvement in Diabetic Retinopathy Severity Score (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). Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
Time Frame
Treatment Period - 12 months (48 weeks)
Title
Summary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data.
Description
Summary of patients developing center-involved Diabetic Macular Edema (DME) or Proliferative Diabetic Retinopathy (PDR) or PDR-related outcomes during treatment period based on Clinical Data. Based on either clinical data or central image reading center evaluation.
Time Frame
Treatment Period - 12 months (48 weeks)
Title
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
Description
Summary of Subjects Developing Center-involved Diabetic Macular Edema (DME) or Proliferative Diabetic Retinopathy (PDR) or Worsening of >=2 Steps Diabetic Retinopathy Severity Scale (DRSS) at Week 48 Based on Central Image Reading Center Evaluation - Study Eyes Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR
Time Frame
Treatment Period - 12 months (48 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Arizona Retina and Vitreous Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Retinal Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Retina Institute of California
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Retina Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retina Consultants of Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Ophthalmic Clinical Trials San Diego
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
California Retina Consultants
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
Facility Name
California Retina Consultants
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Retina Consultants of Southern Colorado
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Rand Eye Institute
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Retina Specialty Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Georgia Retina
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
University Retina
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Illinois Retina Associates
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Wolfe Eye Clinic
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Central Plains Eye MDs
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67226
Country
United States
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212876
Country
United States
Facility Name
Cumberland Valley Retina Consultants PC
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Opthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Specialty Eye Institute
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49202
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Retina Center of New Jersey
City
Bloomfield
State/Province
New Jersey
ZIP/Postal Code
07003
Country
United States
Facility Name
New Jersey Retina
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08820
Country
United States
Facility Name
Retinal and Ophthalmic Consultants P.C.
City
Northfield
State/Province
New Jersey
ZIP/Postal Code
08225
Country
United States
Facility Name
Eye Associates of New Mexico
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Island Retina
City
Shirley
State/Province
New York
ZIP/Postal Code
11967
Country
United States
Facility Name
Retina Vitreous Surgeons of Central New York
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
Facility Name
Retina Associates of Cleveland
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Retina Associates of Cleveland
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Retina Associates of Cleveland
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44505
Country
United States
Facility Name
Retina Vitreous Center
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Facility Name
Mid-Atlantic Retina
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Tennessee Retina
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Texas Retina Associates
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Retina Associates
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Valley Retina Institute
City
Harlingen
State/Province
Texas
ZIP/Postal Code
78550
Country
United States
Facility Name
Retina and Vitreous of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Spokane Eye Clinical Research
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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