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

Sponsor
Paul Yates, MD, PhD (Other)
Overall Status
Completed
CT.gov ID
NCT01782989
Collaborator
MEDARVA Foundation (Other)
286
Enrollment
37
Locations
2
Arms
93
Duration (Months)
7.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
286 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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 Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Nov 1, 2020
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: ORACEA®

40mg doxycycline

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

Drug: Placebo
Placebo capsule daily for 24 months

Outcome Measures

Primary Outcome Measures

  1. Rate of enlargement in area of geographic atrophy in the study eye during the treatment period. [Month 6 and Month 30]

Secondary Outcome Measures

  1. Change in Best Corrected Visual Acuity (BCVA) [Month 6 and Month 30]

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Macula and Retina Institute Glendale California United States 91203
2 Retina Consultants of San Diego Poway California United States 92064
3 Colorado Retina Associates, PC Golden Colorado United States 80401
4 Eldorado Retina Associates Louisville Colorado United States 80027
5 New England Retina Associates Hamden Connecticut United States 06518
6 George Washington University Washington District of Columbia United States 20037
7 Retina Group of Florida Fort Lauderdale Florida United States 33308
8 Medical Center Eye Institute / Gulf Region Clinical Research Institute Pensacola Florida United States 32514
9 Retina Vitreous Associates of Florida Saint Petersburg Florida United States 33703
10 Gailey Eye Clinic Bloomington Illinois United States 61704
11 Retina Associates of Kentucky Lexington Kentucky United States 40509
12 New England Eye Center at Tufts Medical Center Boston Massachusetts United States 02111
13 Harvard Vanguard Medical Associates Boston Massachusetts United States 02215
14 Vitreo-Retinal Associates Worcester Massachusetts United States 01605
15 Retina Specialists of Michigan Grand Rapids Michigan United States 49525
16 Retina Center Minneapolis Minnesota United States 55404
17 Lifelong Vision Foundation Chesterfield Missouri United States 63017
18 Delaware Valley Retina Associates Lawrenceville New Jersey United States 08648
19 Retinal and Ophthalmic Consultants Northfield New Jersey United States 08225
20 New Jersey Retina Toms River New Jersey United States 08755
21 MaculaCare New York New York United States 10021
22 Vitreous Retina Macula Consultants of New York New York New York United States 10022
23 New York Eye and Ear New York New York United States
24 Retina Associates of Western New York Rochester New York United States 14620
25 Cole Eye Institute / Cleveland Clinic Foundation Cleveland Ohio United States 44195
26 Oregon Retina Eugene Oregon United States 97401
27 Pennsylvania Retina Specialists, PC Camp Hill Pennsylvania United States 17011
28 Mid Atlantic Retina / Wills Eye Institute Philadelphia Pennsylvania United States 19107
29 University of Pittsburgh Eye Center Pittsburgh Pennsylvania United States 15213
30 Associates in Ophthalmology, Ltd West Mifflin Pennsylvania United States 15122
31 Retina Research Institute of Texas Abilene Texas United States 79606
32 Brian B. Berger, MD and Associates / Retina Research Center Austin Texas United States 78705
33 Retina Associates of South Texas San Antonio Texas United States 78240
34 University of Virginia Charlottesville Virginia United States 22903
35 Wagner Macula & Retina Center Virginia Beach Virginia United States 23462
36 Virginia Retina Center Warrenton Virginia United States 20186
37 Retina Cosultants Charleston West Virginia United States 25301

Sponsors and Collaborators

  • Paul Yates, MD, PhD
  • MEDARVA Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paul Yates, MD, PhD, Associate Professor of Ophthalmology, University of Virginia
ClinicalTrials.gov Identifier:
NCT01782989
Other Study ID Numbers:
  • 16586
First Posted:
Feb 4, 2013
Last Update Posted:
Apr 29, 2021
Last Verified:
Apr 1, 2021
Keywords provided by Paul Yates, MD, PhD, Associate Professor of Ophthalmology, University of Virginia
geographic atrophy
non-exudative age-related macular degeneration
macular degeneration
dry macular degeneration
dry AMD
Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Atrophy
Doxycycline

Study Results

No Results Posted as of Apr 29, 2021