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



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:55 - Any
Updated:10/12/2018
Start Date:February 2013
End Date:December 2020

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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
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