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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

Sponsor
Aerpio Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT02050828
Collaborator
(none)
144
Enrollment
39
Locations
3
Arms
15.9
Duration (Months)
3.7
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Jan 1, 2014
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

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 Names:
  • 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 Names:
  • Lucentis

    • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Pheonix Arizona United States 85014
    2 Pheonix Arizona United States 85020
    3 Tucson Arizona United States 85704
    4 Arcadia California United States 91007
    5 Bakersfield California United States 93309
    6 Beverly Hills California United States 90211
    7 Palm Desert California United States 92260
    8 Sacramento California United States 95819
    9 Santa Ana California United States 92705
    10 Santa Barbara California United States 93103
    11 Golden Colorado United States 80401
    12 Boynton Beach Florida United States 33426
    13 Fort Lauderdale Florida United States 33334
    14 Fort Myers Florida United States 33912
    15 Miami Florida United States 33126
    16 Sarasota Florida United States 34239
    17 Stuart Florida United States 34994
    18 Winter Haven Florida United States 33880
    19 Baltimore Maryland United States 21287
    20 Jackson Michigan United States 49202
    21 Omaha Nebraska United States 68198
    22 Reno Nevada United States 89502
    23 Rochester New York United States 14620
    24 Charlotte North Carolina United States 28210
    25 Cincinnati Ohio United States 45242
    26 Cleveland Ohio United States 44195
    27 Portland Oregon United States 97210
    28 Florence South Carolina United States 29501
    29 Rapid City South Dakota United States 57701
    30 Nashville Tennessee United States 37203
    31 Abilene Texas United States 79606
    32 Austin Texas United States 78705
    33 Fort Worth Texas United States 76102
    34 Houston Texas United States 77030
    35 McAllen Texas United States 78503
    36 San Antonio Texas United States 78240
    37 Salt Lake City Utah United States 84107
    38 Warrenton Virginia United States 20186
    39 Bellevue Washington United States 98004

    Sponsors and Collaborators

    • Aerpio Therapeutics

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aerpio Therapeutics
    ClinicalTrials.gov Identifier:
    NCT02050828
    Other Study ID Numbers:
    • AKB-9778-CI-2003
    First Posted:
    Jan 31, 2014
    Last Update Posted:
    Mar 16, 2017
    Last Verified:
    Mar 1, 2017
    Additional relevant MeSH terms:
    Macular Edema
    Edema
    Ranibizumab

    Study Results

    No Results Posted as of Mar 16, 2017