Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)
NCT ID: NCT01782989
Last Updated: 2022-11-04
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/PHASE3
286 participants
INTERVENTIONAL
2013-02-28
2020-11-30
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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ORACEA®
40mg doxycycline
ORACEA®
ORACEA® (40mg doxycycline) capsule daily for 24 months
Placebo
Placebo
Placebo capsule daily for 24 months
Interventions
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ORACEA®
ORACEA® (40mg doxycycline) capsule daily for 24 months
Placebo
Placebo capsule daily for 24 months
Eligibility Criteria
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Inclusion Criteria
* Best corrected visual acuity of 20/20 - 20/400 in the study eye
* Best corrected visual acuity of hand motion or better in the non-study eye
* Clinical diagnosis of geographic atrophy secondary to non-exudative age-related macular degeneration in at least one eye (study eye)
* Geographic atrophy lesions of ≥ 0.5 and ≤ 7.0 MPS disc areas
Exclusion Criteria
* History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the non-study eye requiring any treatment within 12 months prior to Day 0 or expected to require treatment for the duration of the study
* Prior treatment for non-exudative age-related macular degeneration
* Current or previous history of treatment of the study eye with any tetracycline derivative for any ocular condition.
* History of vitreoretinal surgery, corneal transplant, or laser photocoagulation in the study eye
* Any intraocular or periocular surgery within 90 days prior to Day 0 in the study eye.
* History of any hypersensitivity to tetracycline components
* Use of a tetracycline derivative therapy for a concurrent systemic or ocular disorder within 90 days of Day 0
* History of sensitivity to the sun
55 Years
ALL
No
Sponsors
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MEDARVA Foundation
UNKNOWN
Paul Yates, MD, PhD
OTHER
Responsible Party
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Paul Yates, MD, PhD
Associate Professor of Ophthalmology
Principal Investigators
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Paul A Yates, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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Macula and Retina Institute
Glendale, California, United States
Retina Consultants of San Diego
Poway, California, United States
Colorado Retina Associates, PC
Golden, Colorado, United States
Eldorado Retina Associates
Louisville, Colorado, United States
New England Retina Associates
Hamden, Connecticut, United States
George Washington University
Washington D.C., District of Columbia, United States
Retina Group of Florida
Fort Lauderdale, Florida, United States
Medical Center Eye Institute / Gulf Region Clinical Research Institute
Pensacola, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
Gailey Eye Clinic
Bloomington, Illinois, United States
Retina Associates of Kentucky
Lexington, Kentucky, United States
New England Eye Center at Tufts Medical Center
Boston, Massachusetts, United States
Harvard Vanguard Medical Associates
Boston, Massachusetts, United States
Vitreo-Retinal Associates
Worcester, Massachusetts, United States
Retina Specialists of Michigan
Grand Rapids, Michigan, United States
Retina Center
Minneapolis, Minnesota, United States
Lifelong Vision Foundation
Chesterfield, Missouri, United States
Delaware Valley Retina Associates
Lawrenceville, New Jersey, United States
Retinal and Ophthalmic Consultants
Northfield, New Jersey, United States
New Jersey Retina
Toms River, New Jersey, United States
MaculaCare
New York, New York, United States
Vitreous Retina Macula Consultants of New York
New York, New York, United States
New York Eye and Ear
New York, New York, United States
Retina Associates of Western New York
Rochester, New York, United States
Cole Eye Institute / Cleveland Clinic Foundation
Cleveland, Ohio, United States
Oregon Retina
Eugene, Oregon, United States
Pennsylvania Retina Specialists, PC
Camp Hill, Pennsylvania, United States
Mid Atlantic Retina / Wills Eye Institute
Philadelphia, Pennsylvania, United States
University of Pittsburgh Eye Center
Pittsburgh, Pennsylvania, United States
Associates in Ophthalmology, Ltd
West Mifflin, Pennsylvania, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Brian B. Berger, MD and Associates / Retina Research Center
Austin, Texas, United States
Retina Associates of South Texas
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Wagner Macula & Retina Center
Virginia Beach, Virginia, United States
Virginia Retina Center
Warrenton, Virginia, United States
Retina Cosultants
Charleston, West Virginia, United States
Countries
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References
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Dalvi S, Roll M, Chatterjee A, Kumar LK, Bhogavalli A, Foley N, Arduino C, Spencer W, Reuben-Thomas C, Ortolan D, Pebay A, Bharti K, Anand-Apte B, Singh R. Human iPSC-based disease modeling studies identify a common mechanistic defect and potential therapies for AMD and related macular dystrophies. Dev Cell. 2024 Dec 16;59(24):3290-3305.e9. doi: 10.1016/j.devcel.2024.09.006. Epub 2024 Oct 2.
Other Identifiers
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16586
Identifier Type: -
Identifier Source: org_study_id
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