Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Geographic Atrophy

In brief

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).

Key facts

Study ID

NCT01782989

Run by

Paul Yates, MD, PhD

People needed

286

Starts

2013-02-01

Expected to finish

2020-11-01

Last updated by the study team

2022-11-04

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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