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

Geographic Atrophy Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01782989
• Other study ID #: 16586
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 2013
• Est. completion date: November 2020

Study information

• Verified date: November 2022
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• ORACEA®
ORACEA® (40mg doxycycline) capsule daily for 24 months
• Placebo
Placebo capsule daily for 24 months

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Brian B. Berger, MD and Associates / Retina Research Center	Austin	Texas
United States	Gailey Eye Clinic	Bloomington	Illinois
United States	Harvard Vanguard Medical Associates	Boston	Massachusetts
United States	New England Eye Center at Tufts Medical Center	Boston	Massachusetts
United States	Pennsylvania Retina Specialists, PC	Camp Hill	Pennsylvania
United States	Retina Cosultants	Charleston	West Virginia
United States	University of Virginia	Charlottesville	Virginia
United States	Lifelong Vision Foundation	Chesterfield	Missouri
United States	Cole Eye Institute / Cleveland Clinic Foundation	Cleveland	Ohio
United States	Oregon Retina	Eugene	Oregon
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	Macula and Retina Institute	Glendale	California
United States	Colorado Retina Associates, PC	Golden	Colorado
United States	Retina Specialists of Michigan	Grand Rapids	Michigan
United States	New England Retina Associates	Hamden	Connecticut
United States	Delaware Valley Retina Associates	Lawrenceville	New Jersey
United States	Retina Associates of Kentucky	Lexington	Kentucky
United States	Eldorado Retina Associates	Louisville	Colorado
United States	Retina Center	Minneapolis	Minnesota
United States	MaculaCare	New York	New York
United States	New York Eye and Ear	New York	New York
United States	Vitreous Retina Macula Consultants of New York	New York	New York
United States	Retinal and Ophthalmic Consultants	Northfield	New Jersey
United States	Medical Center Eye Institute / Gulf Region Clinical Research Institute	Pensacola	Florida
United States	Mid Atlantic Retina / Wills Eye Institute	Philadelphia	Pennsylvania
United States	University of Pittsburgh Eye Center	Pittsburgh	Pennsylvania
United States	Retina Consultants of San Diego	Poway	California
United States	Retina Associates of Western New York	Rochester	New York
United States	Retina Vitreous Associates of Florida	Saint Petersburg	Florida
United States	Retina Associates of South Texas	San Antonio	Texas
United States	New Jersey Retina	Toms River	New Jersey
United States	Wagner Macula & Retina Center	Virginia Beach	Virginia
United States	Virginia Retina Center	Warrenton	Virginia
United States	George Washington University	Washington	District of Columbia
United States	Associates in Ophthalmology, Ltd	West Mifflin	Pennsylvania
United States	Vitreo-Retinal Associates	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Paul Yates, MD, PhD	MEDARVA Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.		Month 6 and Month 30
Secondary	Change in Best Corrected Visual Acuity (BCVA)		Month 6 and Month 30