The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema (TIME-2)

March 15, 2017 updated by: Aerpio Therapeutics

A Phase 2, Randomized, Active-Controlled, Double-Masked, Multi-Center Study to Assess the Safety and Efficacy of Daily Subcutaneous AKB-9778 Administered for 3 Months, as Monotherapy or Adjunctive to Ranibizumab, in Subjects With Diabetic Macular Edema

The purpose of this study is to evaluate the safety and efficacy of AKB-9778 administered as daily subcutaneous injections with and without monthly intravitreal injections of ranibizumab for 3 months in patients with diabetic macular edema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Pheonix, Arizona, United States, 85014
      • Pheonix, Arizona, United States, 85020
      • Tucson, Arizona, United States, 85704
    • California
      • Arcadia, California, United States, 91007
      • Bakersfield, California, United States, 93309
      • Beverly Hills, California, United States, 90211
      • Palm Desert, California, United States, 92260
      • Sacramento, California, United States, 95819
      • Santa Ana, California, United States, 92705
      • Santa Barbara, California, United States, 93103
    • Colorado
      • Golden, Colorado, United States, 80401
    • Florida
      • Boynton Beach, Florida, United States, 33426
      • Fort Lauderdale, Florida, United States, 33334
      • Fort Myers, Florida, United States, 33912
      • Miami, Florida, United States, 33126
      • Sarasota, Florida, United States, 34239
      • Stuart, Florida, United States, 34994
      • Winter Haven, Florida, United States, 33880
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Michigan
      • Jackson, Michigan, United States, 49202
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • Nevada
      • Reno, Nevada, United States, 89502
    • New York
      • Rochester, New York, United States, 14620
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Cleveland, Ohio, United States, 44195
    • Oregon
      • Portland, Oregon, United States, 97210
    • South Carolina
      • Florence, South Carolina, United States, 29501
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Abilene, Texas, United States, 79606
      • Austin, Texas, United States, 78705
      • Fort Worth, Texas, United States, 76102
      • Houston, Texas, United States, 77030
      • McAllen, Texas, United States, 78503
      • San Antonio, Texas, United States, 78240
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • Virginia
      • Warrenton, Virginia, United States, 20186
    • Washington
      • Bellevue, Washington, United States, 98004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

The following is an abbreviated list of inclusion criteria:

  • Adults between 18 to 80 years of age, inclusive
  • Diagnosis of diabetes mellitus (type 1 or type 2)
  • Decrease in vision in the study eye determined to be primarily the result of DME
  • Definite retinal thickening due to diffuse DME involving the central macula in the study eye
  • Central subfield thickness of at least 325 µm by sdOCT with presence of intraretinal fluid in the study eye
  • ETDRS BCVA letter score ≤ 76 and ≥ 24 in the study eye

The following is an abbreviated list of exclusion criteria:

  • Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening
  • History of non infectious uveitis
  • Decrease in visual acuity due to causes other than DME in the study eye

  • History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):

    1. Prior pars plana vitrectomy
    2. Any ocular surgery within 3 months prior to Day 1
    3. YAG capsulotomy within 3 months prior to Day 1
    4. Panretinal scatter photocoagulation (PRP) or focal laser within 3 months prior to Day 1 or anticipated need for PRP during the course of the study
    5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1
    6. Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AKB-9778 15 mg BID monotherapy
Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months.
Drug: Sham
Drug: AKB-9778
Experimental: AKB-9778 15 mg BID + ranibizumab 0.3 mg
Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
Drug: ranibizumab
Other Names:
  • Lucentis
Drug: AKB-9778
Active Comparator: ranibizumab 0.3 mg monotherapy
Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
Drug: Placebo
Drug: ranibizumab
Other Names:
  • Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST)
Time Frame: Month 3
Month 3

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
Time Frame: Month 3
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aerpio Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

January 29, 2014

First Submitted That Met QC Criteria

January 29, 2014

First Posted (Estimate)

January 31, 2014

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

March 15, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKB-9778-CI-2003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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