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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
286

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Paul Yates, MD, PhD

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
MEDARVA Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 4, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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