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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)

Primary Purpose

Diabetic Macular Edema (DME)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AKB-9778
ranibizumab
Placebo
Sham
Sponsored by
Aerpio Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema (DME)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

AKB-9778 15 mg BID monotherapy

AKB-9778 15 mg BID + ranibizumab 0.3 mg

ranibizumab 0.3 mg monotherapy

Arm Description

Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months.

Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.

Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.

Outcomes

Primary Outcome Measures

Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST)

Secondary Outcome Measures

Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)

Full Information

First Posted
January 29, 2014
Last Updated
March 15, 2017
Sponsor
Aerpio Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02050828
Brief Title
The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema
Acronym
TIME-2
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 Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aerpio Therapeutics

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema (DME)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AKB-9778 15 mg BID monotherapy
Arm Type
Experimental
Arm Description
Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus monthly sham intravitreal injection for 3 months.
Arm Title
AKB-9778 15 mg BID + ranibizumab 0.3 mg
Arm Type
Experimental
Arm Description
Subcutaneous AKB-9778 15 mg BID (total daily dose of 30 mg/day) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
Arm Title
ranibizumab 0.3 mg monotherapy
Arm Type
Active Comparator
Arm Description
Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
Intervention Type
Drug
Intervention Name(s)
AKB-9778
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Sham
Primary Outcome Measure Information:
Title
Mean change from baseline in spectral domain optical coherence tomography (sdOCT)-measured central subfield thickness (CST)
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Mean change from baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
Time Frame
Month 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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): Prior pars plana vitrectomy Any ocular surgery within 3 months prior to Day 1 YAG capsulotomy within 3 months prior to Day 1 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 Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Day 1 Prior treatment with intravitreal anti-vascular endothelial growth factor (VEGF) treatment within 8 weeks prior to Day 1
Facility Information:
City
Pheonix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
City
Pheonix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Stuart
State/Province
Florida
ZIP/Postal Code
34994
Country
United States
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49202
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76102
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Warrenton
State/Province
Virginia
ZIP/Postal Code
20186
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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