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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03197870
Recruitment Status : Completed
First Posted : June 23, 2017
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Aerpio Therapeutics

Tracking Information
First Submitted Date  ICMJE June 22, 2017
First Posted Date  ICMJE June 23, 2017
Last Update Posted Date July 31, 2019
Actual Study Start Date  ICMJE June 9, 2017
Actual Primary Completion Date January 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2017)
Percentage of subjects with an improvement in study eye severity of diabetic retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 steps [ Time Frame: Baseline to Week 48 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2017)
  • Secondary outcomes include improvement of DRSS and worsening of DRSS in the study eye, the fellow eye, and both eyes [ Time Frame: Baseline to Week 48 ]
  • Incidence and severity of adverse events [ Time Frame: Baseline to Week 48 ]
  • Change from baseline in clinical laboratory assay results [ Time Frame: Baseline to Week 48 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The TIME-2b Study: A Study of AKB-9778, a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)
Official Title  ICMJE Phase 2 Double-Masked, Placebo-Controlled Study to Assess 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Nonproliferative Diabetic Retinopathy
Intervention  ICMJE
  • Drug: AKB-9778
    Subcutaneous AKB-9778 15mg
  • Drug: Placebo
    Subcutaneous Placebo
Study Arms  ICMJE
  • Experimental: AKB-9778 15mg BID
    Intervention: Drug: AKB-9778
  • Experimental: AKB-9778 15mg QD
    Interventions:
    • Drug: AKB-9778
    • Drug: Placebo
  • Placebo Comparator: Placebo BID
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2018)
167
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2017)
150
Actual Study Completion Date  ICMJE February 9, 2019
Actual Primary Completion Date January 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03197870
Other Study ID Numbers  ICMJE AKB-9778-CI-5001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aerpio Therapeutics
Study Sponsor  ICMJE Aerpio Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aerpio Therapeutics
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP