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

Primary Purpose

Geographic Atrophy

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ORACEA®
Placebo
Sponsored by
Paul Yates, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Geographic Atrophy focused on measuring geographic atrophy, non-exudative age-related macular degeneration, macular degeneration, dry macular degeneration, dry AMD

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Macula and Retina Institute
  • Retina Consultants of San Diego
  • Colorado Retina Associates, PC
  • Eldorado Retina Associates
  • New England Retina Associates
  • George Washington University
  • Retina Group of Florida
  • Medical Center Eye Institute / Gulf Region Clinical Research Institute
  • Retina Vitreous Associates of Florida
  • Gailey Eye Clinic
  • Retina Associates of Kentucky
  • New England Eye Center at Tufts Medical Center
  • Harvard Vanguard Medical Associates
  • Vitreo-Retinal Associates
  • Retina Specialists of Michigan
  • Retina Center
  • Lifelong Vision Foundation
  • Delaware Valley Retina Associates
  • Retinal and Ophthalmic Consultants
  • New Jersey Retina
  • MaculaCare
  • Vitreous Retina Macula Consultants of New York
  • New York Eye and Ear
  • Retina Associates of Western New York
  • Cole Eye Institute / Cleveland Clinic Foundation
  • Oregon Retina
  • Pennsylvania Retina Specialists, PC
  • Mid Atlantic Retina / Wills Eye Institute
  • University of Pittsburgh Eye Center
  • Associates in Ophthalmology, Ltd
  • Retina Research Institute of Texas
  • Brian B. Berger, MD and Associates / Retina Research Center
  • Retina Associates of South Texas
  • University of Virginia
  • Wagner Macula & Retina Center
  • Virginia Retina Center
  • Retina Cosultants

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ORACEA®

Placebo

Arm Description

40mg doxycycline

Outcomes

Primary Outcome Measures

Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.

Secondary Outcome Measures

Change in Best Corrected Visual Acuity (BCVA)

Full Information

First Posted
January 31, 2013
Last Updated
November 3, 2022
Sponsor
Paul Yates, MD, PhD
Collaborators
MEDARVA Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01782989
Brief Title
Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)
Acronym
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
November 2020 (Actual)
Study Completion Date
November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paul Yates, MD, PhD
Collaborators
MEDARVA Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Geographic Atrophy
Keywords
geographic atrophy, non-exudative age-related macular degeneration, macular degeneration, dry macular degeneration, dry AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ORACEA®
Arm Type
Experimental
Arm Description
40mg doxycycline
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ORACEA®
Intervention Description
ORACEA® (40mg doxycycline) capsule daily for 24 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule daily for 24 months
Primary Outcome Measure Information:
Title
Rate of enlargement in area of geographic atrophy in the study eye during the treatment period.
Time Frame
Month 6 and Month 30
Secondary Outcome Measure Information:
Title
Change in Best Corrected Visual Acuity (BCVA)
Time Frame
Month 6 and Month 30

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Yates, MD, PhD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Macula and Retina Institute
City
Glendale
State/Province
California
ZIP/Postal Code
91203
Country
United States
Facility Name
Retina Consultants of San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Facility Name
Colorado Retina Associates, PC
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Eldorado Retina Associates
City
Louisville
State/Province
Colorado
ZIP/Postal Code
80027
Country
United States
Facility Name
New England Retina Associates
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Medical Center Eye Institute / Gulf Region Clinical Research Institute
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Retina Vitreous Associates of Florida
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33703
Country
United States
Facility Name
Gailey Eye Clinic
City
Bloomington
State/Province
Illinois
ZIP/Postal Code
61704
Country
United States
Facility Name
Retina Associates of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
New England Eye Center at Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Harvard Vanguard Medical Associates
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Vitreo-Retinal Associates
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Retina Specialists of Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
Retina Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Lifelong Vision Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Delaware Valley Retina Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Retinal and Ophthalmic Consultants
City
Northfield
State/Province
New Jersey
ZIP/Postal Code
08225
Country
United States
Facility Name
New Jersey Retina
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
MaculaCare
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Vitreous Retina Macula Consultants of New York
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
New York Eye and Ear
City
New York
State/Province
New York
Country
United States
Facility Name
Retina Associates of Western New York
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Cole Eye Institute / Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Retina
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Pennsylvania Retina Specialists, PC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Mid Atlantic Retina / Wills Eye Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Associates in Ophthalmology, Ltd
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Brian B. Berger, MD and Associates / Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Associates of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Wagner Macula & Retina Center
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Virginia Retina Center
City
Warrenton
State/Province
Virginia
ZIP/Postal Code
20186
Country
United States
Facility Name
Retina Cosultants
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25301
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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