Clinical trial NCT01782989: Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)
Official title: A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Geographic Atrophy
Keywords: geographic atrophy
non-exudative age-related macular degeneration
macular degeneration
dry macular degeneration
dry AMD
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: MEDARVA Foundation
First posted: 2013-02-04
Enrollment: 286
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility 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

Primary outcomes:
measure: Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.
timeFrame: Month 6 and Month 30
Secondary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA)
timeFrame: Month 6 and Month 30
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Macula and Retina Institute
state: California
city: Poway
country: United States
facility: Retina Consultants of San Diego
state: California
city: Golden
country: United States
facility: Colorado Retina Associates, PC
state: Colorado
city: Louisville
country: United States
facility: Eldorado Retina Associates
state: Colorado
city: Hamden
country: United States
facility: New England Retina Associates
state: Connecticut
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Pensacola
country: United States
facility: Medical Center Eye Institute / Gulf Region Clinical Research Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Bloomington
country: United States
facility: Gailey Eye Clinic
state: Illinois
city: Lexington
country: United States
facility: Retina Associates of Kentucky
state: Kentucky
city: Boston
country: United States
facility: New England Eye Center at Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
city: Worcester
country: United States
facility: Vitreo-Retinal Associates
state: Massachusetts
city: Grand Rapids
country: United States
facility: Retina Specialists of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Retina Center
state: Minnesota
city: Chesterfield
country: United States
facility: Lifelong Vision Foundation
state: Missouri
city: Lawrenceville
country: United States
facility: Delaware Valley Retina Associates
state: New Jersey
city: Northfield
country: United States
facility: Retinal and Ophthalmic Consultants
state: New Jersey
city: Toms River
country: United States
facility: New Jersey Retina
state: New Jersey
city: New York
country: United States
facility: MaculaCare
state: New York
city: New York
country: United States
facility: Vitreous Retina Macula Consultants of New York
state: New York
city: New York
country: United States
facility: New York Eye and Ear
state: New York
city: Rochester
country: United States
facility: Retina Associates of Western New York
state: New York
city: Cleveland
country: United States
facility: Cole Eye Institute / Cleveland Clinic Foundation
state: Ohio
city: Eugene
country: United States
facility: Oregon Retina
state: Oregon
city: Camp Hill
country: United States
facility: Pennsylvania Retina Specialists, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Mid Atlantic Retina / Wills Eye Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Eye Center
state: Pennsylvania
city: West Mifflin
country: United States
facility: Associates in Ophthalmology, Ltd
state: Pennsylvania
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Brian B. Berger, MD and Associates / Retina Research Center
state: Texas
city: San Antonio
country: United States
facility: Retina Associates of South Texas
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Virginia Beach
country: United States
facility: Wagner Macula & Retina Center
state: Virginia
city: Warrenton
country: United States
facility: Virginia Retina Center
state: Virginia
city: Charleston
country: United States
facility: Retina Cosultants
state: West Virginia
Study officials:
affiliation: University of Virginia
name: Paul A Yates, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: