Overview

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