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

A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration

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).

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.

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