Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 10/12/2018 |
| Start Date: | February 2013 |
| End Date: | December 2020 |
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).
treatment of geographic atrophy due to dry age-related macular degeneration (AMD).
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.
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.
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
We found this trial at
37
sites
Glendale, California 91203
Principal Investigator: Kent Small, MD
Phone: 818-552-5040
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Abilene, Texas 79606
Principal Investigator: Grant Janzen, MD
Phone: 325-690-4414
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Austin, Texas 78705
Principal Investigator: Brian B. Berger, MD
Phone: 512-279-1252
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Bloomington, Illinois 61704
Principal Investigator: Sumit Bhatia, MD
Phone: 309-829-5311
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Boston, Massachusetts 02111
Principal Investigator: Andre Witkin, MD
Phone: 617-636-4600
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Boston, Massachusetts
Principal Investigator: Christopher Andreoli, MD
Phone: 617-421-3352
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Camp Hill, Pennsylvania 17011
Principal Investigator: Jay Prensky, MD
Phone: 717-761-8688
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331 Laidley Street
Charleston, West Virginia 25301
Charleston, West Virginia 25301
Principal Investigator: Scott Jamerson, MD
Phone: 304-346-4400
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Charlottesville, Virginia 22903
(434) 924-0311
Principal Investigator: Paul Yates, MD, PhD
Phone: 434-243-5737
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Chesterfield, Missouri 63017
Principal Investigator: Nancy Holekamp, MD
Phone: 636-534-5106
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Cleveland, Ohio 44195
Principal Investigator: Rishi Singh, MD
Phone: 216-445-5248
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Fort Lauderdale, Florida 33334
Principal Investigator: Darin Goldman, MD
Phone: 954-776-6880
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Golden, Colorado 80401
Principal Investigator: Brian Joondeph, MD
Phone: 303-261-1600
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Grand Rapids, Michigan
Principal Investigator: Thomas Aaberg, MD
Phone: 616-954-2020
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Hamden, Connecticut 06518
Principal Investigator: David Tom, MD
Phone: 203-288-2020
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Lawrenceville, New Jersey 08648
Principal Investigator: Darma Ie, MD
Phone: 609-896-1414
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Lexington, Kentucky 40509
Principal Investigator: Rick Isernhagen, MD
Phone: 859-264-2905
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Louisville, Colorado 80027
Principal Investigator: Mary Lansing, MD
Phone: 303-666-1800
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Minneapolis, Minnesota 55404
Principal Investigator: Abdhish Bhavsar, MD
Phone: 800-233-8504
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New York, New York 10021
Principal Investigator: Daniel Rosberger, MD
Phone: 212-439-9600
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New York, New York 10022
Principal Investigator: K. Bailey Freund, MD
Phone: 212-452-6965
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Northfield, New Jersey
Principal Investigator: Scott Foxman, MD
Phone: 609-646-5200
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Pensacola, Florida 32514
Principal Investigator: Van Aldred, MD
Phone: 850-969-2560
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Philadelphia, Pennsylvania 19107
Principal Investigator: Omesh Gupta, MD
Phone: 215-928-3092
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Thomas Friberg, MD
Phone: 412-647-7603
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Poway, California 92064
Principal Investigator: Nikolas London, MD
Phone: 858-451-1911
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Rochester, New York 14618
Principal Investigator: Edward Hall, MD
Phone: 585-442-3411
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4344 Central Avenue North
Saint Petersburg, Florida 33711
Saint Petersburg, Florida 33711
Principal Investigator: David Eichenbaum, MD
Phone: 727-323-0077
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San Antonio, Texas 78240
Principal Investigator: Lina Marouf, MD
Phone: 210-615-7600
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Toms River, New Jersey 08755
Principal Investigator: Sumit Shah, MD
Phone: 732-797-3984
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Virginia Beach, Virginia
Principal Investigator: Kapil Kapoor, MD
Phone: 757-481-4400
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Warrenton, Virginia 20186
Principal Investigator: Sam Mansour, MD
Phone: 540-349-1882
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West Mifflin, Pennsylvania 15122
Principal Investigator: Miguel Busquets, MD
Phone: 412-653-3080
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Worcester, Massachusetts 01605
Principal Investigator: Frank McCabe, MD
Phone: 508-752-1155
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