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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ACTIVE_NOT_RECRUITING
PHASE2
128 participants
INTERVENTIONAL
2023-05-02
2026-01-31
Brief Summary
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Detailed Description
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Exploratory objectives will evaluate biomarkers of kidney function for potential benefit. Furthermore, this phase 2 study is being conducted to determine whether the conduct of a phase 3 trial has merit and provide information on outcome measures needed to design a phase 3 trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Two pills of Study Drug (placebo) is taken orally once daily. It is recommended the Study Drug be taken at bedtime. The first dose (two pills) will be taken at bedtime on the day the participant is randomized.
Tonabersat (80 mg)
Tonabersat
Two pills of Study Drug (80 mg tonabersat) is taken orally once daily. It is recommended the Study Drug be taken at bedtime. The first dose (two pills) will be taken at bedtime on the day the participant is randomized.
Interventions
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Tonabersat
Two pills of Study Drug (80 mg tonabersat) is taken orally once daily. It is recommended the Study Drug be taken at bedtime. The first dose (two pills) will be taken at bedtime on the day the participant is randomized.
Placebo
Two pills of Study Drug (placebo) is taken orally once daily. It is recommended the Study Drug be taken at bedtime. The first dose (two pills) will be taken at bedtime on the day the participant is randomized.
Eligibility Criteria
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Inclusion Criteria
2. At least one eye with:
* Best corrected E-ETDRS visual acuity letter score ≥ 74 (i.e., 20/32 or better)
* Ophthalmoscopic evidence of center-involved DME in study eye confirmed by central subfield thickness on spectral domain OCT
* Zeiss Cirrus: ≥ 290 µm in females, ≥ 305 µm in males
* Heidelberg Spectralis: ≥ 305 µm in females, ≥ 320 µm in males
* Recruitment will be monitored with a goal to have equal proportions in the following categories above the CI-DME thresholds: \<75 μm, 75 μm to \<175 μm, ≥175 μm
3. Media clarity, pupillary dilation, and study participant cooperation sufficient for adequate OCT
Exclusion Criteria
* Major ocular surgery within prior 4 months, or anticipated after randomization
* History of focal/grid laser or other ocular surgical, intravitreal, or peribulbar treatment for DR or DME within prior 1 year, and no more than 4 anti-VEGF injections within prior 3 years
* Anticipated need to treat DME or DR during the first 6 months, or anticipated need for cataract surgery during study period
* Any history of vitrectomy
* Systemic anti-VEGF or pro-VEGF treatment within 12 months prior to randomization
* History of chronic renal failure requiring dialysis or kidney transplant
* History of moderate to severe hepatic impairment, including known liver function test (LFT) values \> 3x's the upper limit of normal
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Eye Institute (NEI)
NIH
Juvenile Diabetes Research Foundation
OTHER
Jaeb Center for Health Research
OTHER
Responsible Party
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Locations
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Retina Associates of Southern California
Huntington Beach, California, United States
Loma Linda University
Loma Linda, California, United States
East Bay Retina Consultants, Inc.
Oakland, California, United States
Southern California Desert Retina Consultants, Inc.
Palm Desert, California, United States
Macula Retina Vitreous Institute
Torrance, California, United States
National Ophthalmic Research Institute
Fort Myers, Florida, United States
University of Florida- Jacksonville
Jacksonville, Florida, United States
Central Florida Retina Institute
Lakeland, Florida, United States
Florida Retina Consultants
Lakeland, Florida, United States
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida, United States
Southeast Retina Center
Augusta, Georgia, United States
Thomas Eye Group
Sandy Springs, Georgia, United States
Illinois Retina Associates
Oak Park, Illinois, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Joseph E. Humble and Raymond Haik PTRS DBA Eye Assoc of Northeast Louisiana
West Monroe, Louisiana, United States
Elman Retina Group
Baltimore, Maryland, United States
Boston Medical Center Corporation
Boston, Massachusetts, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Retina Research Institute, LLC
St Louis, Missouri, United States
Retina-Vitreous Surgeons of Central NY, PC
Liverpool, New York, United States
Verum Research LLC
Eugene, Oregon, United States
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Pittsburg Clinical Trial Consortium
Sewickley, Pennsylvania, United States
Hilton Head Retina Institute
Hilton Head Island, South Carolina, United States
Retina Consultants of Texas, PA
Bellaire, Texas, United States
Texas Retina Associates
Lubbock, Texas, United States
Retinal Consultants of Texas
San Antonio, Texas, United States
Countries
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Other Identifiers
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DRCR Protocol AN
Identifier Type: -
Identifier Source: org_study_id
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