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

Paul Yates, MD, PhD

Status and phase

Completed

Phase 3

Phase 2

Conditions

Geographic Atrophy

Treatments

Drug: Placebo

Drug: ORACEA®

Study type

Interventional

Funder types

Other

Identifiers

NCT01782989

16586

Details and patient eligibility

About

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).

Full 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.

Enrollment

286 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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