Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)
TOGA
A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration
1 other identifier
interventional
286
1 country
37
Brief Summary
This is a prospective, randomized study to evaluate the efficacy and safety of ORACEA® in the treatment of geographic atrophy due to dry age-related macular degeneration (AMD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2013
Longer than P75 for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
February 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedNovember 4, 2022
November 1, 2022
7.8 years
January 31, 2013
November 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.
Month 6 and Month 30
Secondary Outcomes (1)
Change in Best Corrected Visual Acuity (BCVA)
Month 6 and Month 30
Study Arms (2)
ORACEA®
EXPERIMENTAL40mg doxycycline
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female, age \>/=55 years
- 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
You may not qualify if:
- History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the study eye
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paul Yates, MD, PhDlead
- MEDARVA Foundationcollaborator
Study Sites (37)
Macula and Retina Institute
Glendale, California, 91203, United States
Retina Consultants of San Diego
Poway, California, 92064, United States
Colorado Retina Associates, PC
Golden, Colorado, 80401, United States
Eldorado Retina Associates
Louisville, Colorado, 80027, United States
New England Retina Associates
Hamden, Connecticut, 06518, United States
George Washington University
Washington D.C., District of Columbia, 20037, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
Medical Center Eye Institute / Gulf Region Clinical Research Institute
Pensacola, Florida, 32514, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33703, United States
Gailey Eye Clinic
Bloomington, Illinois, 61704, United States
Retina Associates of Kentucky
Lexington, Kentucky, 40509, United States
New England Eye Center at Tufts Medical Center
Boston, Massachusetts, 02111, United States
Harvard Vanguard Medical Associates
Boston, Massachusetts, 02215, United States
Vitreo-Retinal Associates
Worcester, Massachusetts, 01605, United States
Retina Specialists of Michigan
Grand Rapids, Michigan, 49525, United States
Retina Center
Minneapolis, Minnesota, 55404, United States
Lifelong Vision Foundation
Chesterfield, Missouri, 63017, United States
Delaware Valley Retina Associates
Lawrenceville, New Jersey, 08648, United States
Retinal and Ophthalmic Consultants
Northfield, New Jersey, 08225, United States
New Jersey Retina
Toms River, New Jersey, 08755, United States
MaculaCare
New York, New York, 10021, United States
Vitreous Retina Macula Consultants of New York
New York, New York, 10022, United States
New York Eye and Ear
New York, New York, United States
Retina Associates of Western New York
Rochester, New York, 14620, United States
Cole Eye Institute / Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Oregon Retina
Eugene, Oregon, 97401, United States
Pennsylvania Retina Specialists, PC
Camp Hill, Pennsylvania, 17011, United States
Mid Atlantic Retina / Wills Eye Institute
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Eye Center
Pittsburgh, Pennsylvania, 15213, United States
Associates in Ophthalmology, Ltd
West Mifflin, Pennsylvania, 15122, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Brian B. Berger, MD and Associates / Retina Research Center
Austin, Texas, 78705, United States
Retina Associates of South Texas
San Antonio, Texas, 78240, United States
University of Virginia
Charlottesville, Virginia, 22903, United States
Wagner Macula & Retina Center
Virginia Beach, Virginia, 23462, United States
Virginia Retina Center
Warrenton, Virginia, 20186, United States
Retina Cosultants
Charleston, West Virginia, 25301, United States
Related Publications (1)
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.
PMID: 39362220DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paul A Yates, MD, PhD
University of Virginia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor of Ophthalmology
Study Record Dates
First Submitted
January 31, 2013
First Posted
February 4, 2013
Study Start
February 1, 2013
Primary Completion
November 1, 2020
Study Completion
November 1, 2020
Last Updated
November 4, 2022
Record last verified: 2022-11