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

• Status: Completed
• Trial end date: 2020-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Paul Yates, MD, PhD
• Collaborator: MEDARVA Foundation
• Treatments: Doxycycline

Criteria

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