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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
144

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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