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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)

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ClinicalTrials.gov Identifier: NCT03197870
Recruitment Status : Active, not recruiting
First Posted : June 23, 2017
Last Update Posted : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
Aerpio Therapeutics

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).

Condition or disease Intervention/treatment Phase
Nonproliferative Diabetic Retinopathy Drug: AKB-9778 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : June 29, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: AKB-9778 15mg BID Drug: AKB-9778
Subcutaneous AKB-9778 15mg
Experimental: AKB-9778 15mg QD Drug: AKB-9778
Subcutaneous AKB-9778 15mg
Drug: Placebo
Subcutaneous Placebo
Placebo Comparator: Placebo BID Drug: Placebo
Subcutaneous Placebo



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Incidence and severity of adverse events [ Time Frame: Baseline to Week 48 ]
  3. Change from baseline in clinical laboratory assay results [ Time Frame: Baseline to Week 48 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197870


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Sponsors and Collaborators
Aerpio Therapeutics

Responsible Party: Aerpio Therapeutics
ClinicalTrials.gov Identifier: NCT03197870     History of Changes
Other Study ID Numbers: AKB-9778-CI-5001
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases