Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema
NCT ID: NCT01702441
Last Updated: 2015-03-27
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
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2012-09-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AKB-9778
Up to 4 dose levels of subcutaneous AKB-9778 will be evaluated. Doses will be administered daily for 28 days.
Subcutaneous AKB-9778
Interventions
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Subcutaneous AKB-9778
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of diabetes mellitus (type 1 or type 2)
* Decrease in vision determined to be primarily the result of DME in the study eye
* Definite Retinal thickening due to diffuse DME involving the center of the macula in the study eye
* Mean central subfield thickness of at least 325 µm by OCT in the study eye
* Early Treatment Diabetic Retinopathy Study (ETDRS) letter score BCVA ≤ 70 (20/40) in the study eye
Exclusion Criteria
* History of any of the following in the study eye (however, the following are not exclusionary in the fellow eye):
1. Panretinal scatter photocoagulation (PRP) or focal laser within 12 weeks prior to Screening
2. Prior pars plana vitrectomy within 12 weeks prior to Screening
3. Any ocular surgery within 12 weeks prior to Screening
4. YAG capsulotomy within 7 days prior to Screening
5. Prior intravitreal, subtenon, or periocular steroid therapy within 3 months prior to Screening or prior treatment with intravitreal anti-VEGF treatment within 1 month of Screening
18 Years
80 Years
ALL
No
Sponsors
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Aerpio Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Kevin Peters, MD
Role: STUDY_DIRECTOR
Aerpio Therapeutics
Locations
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Beverly Hills, California, United States
Winter Haven, Florida, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Countries
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Other Identifiers
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AKB-9778-CI-2002
Identifier Type: -
Identifier Source: org_study_id
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