We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02050828
First Posted: January 31, 2014
Last Update Posted: March 16, 2017
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.
Information provided by (Responsible Party):
Aerpio Therapeutics
  Purpose
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.

Condition Intervention Phase
Diabetic Macular Edema (DME) Drug: AKB-9778 Drug: ranibizumab Drug: Placebo Drug: Sham Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Aerpio Therapeutics:

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

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

Enrollment: 144
Study Start Date: January 2014
Study Completion Date: May 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: AKB-9778 Drug: Sham
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: AKB-9778 Drug: ranibizumab
Other Name: Lucentis
Active Comparator: ranibizumab 0.3 mg monotherapy
Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
Drug: ranibizumab
Other Name: Lucentis
Drug: Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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): NCT02050828


  Show 39 Study Locations
Sponsors and Collaborators
Aerpio Therapeutics
  More Information

Responsible Party: Aerpio Therapeutics
ClinicalTrials.gov Identifier: NCT02050828     History of Changes
Other Study ID Numbers: AKB-9778-CI-2003
First Submitted: January 29, 2014
First Posted: January 31, 2014
Last Update Posted: March 16, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents