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

November 3, 2022 updated by: Paul Yates, MD, PhD

A Randomized, Double Blind, Placebo Controlled Study Evaluating ORACEA® in Subjects With Geographic Atrophy Secondary to Non-Exudative Age-Related Macular Degeneration

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

286

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91203
        • Macula and Retina Institute
      • Poway, California, United States, 92064
        • Retina Consultants of San Diego
    • Colorado
      • Golden, Colorado, United States, 80401
        • Colorado Retina Associates, PC
      • Louisville, Colorado, United States, 80027
        • Eldorado Retina Associates
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • New England Retina Associates
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Retina Group of Florida
      • Pensacola, Florida, United States, 32514
        • Medical Center Eye Institute / Gulf Region Clinical Research Institute
      • Saint Petersburg, Florida, United States, 33703
        • Retina Vitreous Associates of Florida
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Gailey Eye Clinic
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Retina Associates of Kentucky
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Harvard Vanguard Medical Associates
      • Boston, Massachusetts, United States, 02111
        • New England Eye Center at Tufts Medical Center
      • Worcester, Massachusetts, United States, 01605
        • Vitreo-Retinal Associates
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Retina Specialists of Michigan
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Retina Center
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Lifelong Vision Foundation
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Delaware Valley Retina Associates
      • Northfield, New Jersey, United States, 08225
        • Retinal and Ophthalmic Consultants
      • Toms River, New Jersey, United States, 08755
        • New Jersey Retina
    • New York
      • New York, New York, United States, 10021
        • MaculaCare
      • New York, New York, United States, 10022
        • Vitreous Retina Macula Consultants of New York
      • New York, New York, United States
        • New York Eye and Ear
      • Rochester, New York, United States, 14620
        • Retina Associates of Western New York
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cole Eye Institute / Cleveland Clinic Foundation
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Retina
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Pennsylvania Retina Specialists, PC
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina / Wills Eye Institute
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Eye Center
      • West Mifflin, Pennsylvania, United States, 15122
        • Associates in Ophthalmology, Ltd
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Austin, Texas, United States, 78705
        • Brian B. Berger, MD and Associates / Retina Research Center
      • San Antonio, Texas, United States, 78240
        • Retina Associates of South Texas
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Wagner Macula & Retina Center
      • Warrenton, Virginia, United States, 20186
        • Virginia Retina Center
    • West Virginia
      • Charleston, West Virginia, United States, 25301
        • Retina Cosultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo capsule daily for 24 months
Experimental: ORACEA®
40mg doxycycline
Drug: ORACEA®
ORACEA® (40mg doxycycline) capsule daily for 24 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.
Time Frame: Month 6 and Month 30
Month 6 and Month 30

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Best Corrected Visual Acuity (BCVA)
Time Frame: Month 6 and Month 30
Month 6 and Month 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Yates, MD, PhD

Collaborators

MEDARVA Foundation

Investigators

  • Principal Investigator: Paul A Yates, MD, PhD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

January 31, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimate)

February 4, 2013

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16586

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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