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 |
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).
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.
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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