Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)
Purpose
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).
Condition
- Geographic Atrophy
Eligibility
- Eligible Ages
- Over 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2/Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ORACEA® |
40mg doxycycline |
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT01782989
- Status
- Completed
- Sponsor
- Paul Yates, MD, PhD
Detailed Description
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.