Geographic Atrophy

Toga Study

About The Study:

Sponsored by the University of Virginia, Department of Ophthalmology, the purpose of this multi-center study is to assess the safety and effectiveness of ORACEA, to determine if it can slow the progression of geographic atrophy in participants who have geographic atrophy. ORACEA is an investigational drug and has not yet been proven safe or helpful in patients with dry AMD.

All participants will be randomized to one of two study groups. The groups are:

Group A—ORACEA (40 mg doxycycline)
Group B—Placebo capsule

Participants participating in this study will have approximately 6 scheduled study visits over a period of 24 months. Each visit will last about 1-3 hours.

Key Inclusion Criteria:

Age ≥ 55 years
BCVA of 20/20-20/400 in the study eye
BCVA of hand motion or better in the non-study eye
Diagnosis of geographic atrophy (GA) in at least one eye
Geographic atrophy lesions between 0.75-7.0 MPS disc areas

Key Exclusion Criteria:

CNV requiring treatment within the past 12 months
Treatment with any anti-VEGF agent in the study eye
Vitreoretinal surgery, corneal transplant, or laser photocoagulation in the study eye
Previous glaucoma filtration surgery in the study eye
Uncontrolled glaucoma (IOP > 22 mmHg)
Use of anticoagulant therapies (up to 325 mg of Aspirin allowed)
Hypersensitivity to tetracycline components

For additional information on any study or to refer a patient contact the study coordinators:

Ashton Leone, MPH at (434) 243-5737 or aml7q@virginia.edu
Tamika Mercer at (434) 243-2852 or tmm2v@virginia.edu