Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA) (NCT01782989) | Clinical Trial Compass
CompletedPhase 2/3
Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)
United States286 participantsStarted 2013-02
Plain-language 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).
Who can participate
Age range55 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.