Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)
- Registration Number
- NCT01782989
- Lead Sponsor
- Paul Yates, MD, PhD
- 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).
- Detailed Description
Eligible participants will complete a 6-month Observation Phase, followed by a 24-month Treatment Phase, followed by an End of Study Visit. Eligible participants will be randomized at Month 6 in a 1:1 ratio to either ORACEA (40 mg doxycycline) or placebo capsule to be taken once-daily for 24 months. Over the course of the 31-month study, a total of 9 clinic visits and 3 telephone calls are required.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 286
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ORACEA® ORACEA® 40mg doxycycline Placebo Placebo -
- Primary Outcome Measures
Name Time Method Rate of enlargement in area of geographic atrophy in the study eye during the treatment period. Month 6 and Month 30
- Secondary Outcome Measures
Name Time Method Change in Best Corrected Visual Acuity (BCVA) Month 6 and Month 30
Trial Locations
- Locations (37)
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
Eldorado Retina Associates
🇺🇸Louisville, Colorado, United States
Vitreo-Retinal Associates
🇺🇸Worcester, Massachusetts, United States
Lifelong Vision Foundation
🇺🇸Chesterfield, Missouri, United States
Mid Atlantic Retina / Wills Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Eye Center
🇺🇸Pittsburgh, Pennsylvania, United States
Cole Eye Institute / Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
New England Eye Center at Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Retina Center
🇺🇸Minneapolis, Minnesota, United States
Retina Associates of South Texas
🇺🇸San Antonio, Texas, United States
Delaware Valley Retina Associates
🇺🇸Lawrenceville, New Jersey, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
New Jersey Retina
🇺🇸Toms River, New Jersey, United States
Retina Cosultants
🇺🇸Charleston, West Virginia, United States
New England Retina Associates
🇺🇸Hamden, Connecticut, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
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
Medical Center Eye Institute / Gulf Region Clinical Research Institute
🇺🇸Pensacola, Florida, United States
Retina Vitreous Associates of Florida
🇺🇸Saint Petersburg, Florida, United States
Harvard Vanguard Medical Associates
🇺🇸Boston, Massachusetts, United States
Gailey Eye Clinic
🇺🇸Bloomington, Illinois, United States
Retina Specialists of Michigan
🇺🇸Grand Rapids, Michigan, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, 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
Pennsylvania Retina Specialists, PC
🇺🇸Camp Hill, Pennsylvania, United States
Oregon Retina
🇺🇸Eugene, Oregon, 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
Wagner Macula & Retina Center
🇺🇸Virginia Beach, Virginia, United States
Virginia Retina Center
🇺🇸Warrenton, Virginia, United States
Retinal and Ophthalmic Consultants
🇺🇸Northfield, New Jersey, United States