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

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: NCT02050828
Recruitment Status : Completed
First Posted : January 31, 2014
Last Update Posted : March 16, 2017
Sponsor:
Information provided by (Responsible Party):
Aerpio Therapeutics

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetic Macular Edema (DME) Drug: AKB-9778 Drug: ranibizumab Drug: Placebo Drug: Sham Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
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
Study Start Date : January 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ranibizumab

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: 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



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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


Locations
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United States, Arizona
Pheonix, Arizona, United States, 85014
Pheonix, Arizona, United States, 85020
Tucson, Arizona, United States, 85704
United States, 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
United States, Colorado
Golden, Colorado, United States, 80401
United States, 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
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, Michigan
Jackson, Michigan, United States, 49202
United States, Nebraska
Omaha, Nebraska, United States, 68198
United States, Nevada
Reno, Nevada, United States, 89502
United States, New York
Rochester, New York, United States, 14620
United States, North Carolina
Charlotte, North Carolina, United States, 28210
United States, Ohio
Cincinnati, Ohio, United States, 45242
Cleveland, Ohio, United States, 44195
United States, Oregon
Portland, Oregon, United States, 97210
United States, South Carolina
Florence, South Carolina, United States, 29501
United States, South Dakota
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, 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
United States, Utah
Salt Lake City, Utah, United States, 84107
United States, Virginia
Warrenton, Virginia, United States, 20186
United States, Washington
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Aerpio Therapeutics

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Responsible Party: Aerpio Therapeutics
ClinicalTrials.gov Identifier: NCT02050828    
Other Study ID Numbers: AKB-9778-CI-2003
First Posted: January 31, 2014    Key Record Dates
Last Update Posted: March 16, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents