The TIME-2 Study: A Phase 2 Study of AKB-9778, a Novel Tie-2 Activator, in Patients With Diabetic Macular Edema
NCT ID: NCT02050828
Last Updated: 2017-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
144 participants
INTERVENTIONAL
2014-01-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
AKB-9778
Sham
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.
AKB-9778
ranibizumab
ranibizumab 0.3 mg monotherapy
Placebo subcutaneous injection (BID) plus ranibizumab 0.3 mg monthly intravitreal injection for 3 months.
ranibizumab
Placebo
Interventions
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AKB-9778
ranibizumab
Placebo
Sham
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Aerpio Therapeutics
INDUSTRY
Responsible Party
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Locations
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Pheonix, Arizona, United States
Pheonix, Arizona, United States
Tucson, Arizona, United States
Arcadia, California, United States
Bakersfield, California, United States
Beverly Hills, California, United States
Palm Desert, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Santa Barbara, California, United States
Golden, Colorado, United States
Boynton Beach, Florida, United States
Fort Lauderdale, Florida, United States
Fort Myers, Florida, United States
Miami, Florida, United States
Sarasota, Florida, United States
Stuart, Florida, United States
Winter Haven, Florida, United States
Baltimore, Maryland, United States
Jackson, Michigan, United States
Omaha, Nebraska, United States
Reno, Nevada, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Florence, South Carolina, United States
Rapid City, South Dakota, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
McAllen, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Warrenton, Virginia, United States
Bellevue, Washington, United States
Countries
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Other Identifiers
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AKB-9778-CI-2003
Identifier Type: -
Identifier Source: org_study_id
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