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

Use our guide to learn which trials are right for you!

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).

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.

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
331 Laidley Street
Charleston, West Virginia 25301
Principal Investigator: Scott Jamerson, MD
Phone: 304-346-4400
133
mi
from 43215
Charleston, WV
Click here to add this to my saved trials
Abilene, Texas 79606
Principal Investigator: Grant Janzen, MD
Phone: 325-690-4414
1070
mi
from 43215
Abilene, TX
Click here to add this to my saved trials
Austin, Texas 78705
Principal Investigator: Brian B. Berger, MD
Phone: 512-279-1252
1065
mi
from 43215
Austin, TX
Click here to add this to my saved trials
Bloomington, Illinois 61704
Principal Investigator: Sumit Bhatia, MD
Phone: 309-829-5311
313
mi
from 43215
Bloomington, IL
Click here to add this to my saved trials
Boston, Massachusetts 02111
Principal Investigator: Andre Witkin, MD
Phone: 617-636-4600
642
mi
from 43215
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts
Principal Investigator: Christopher Andreoli, MD
Phone: 617-421-3352
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
Camp Hill, Pennsylvania 17011
Principal Investigator: Jay Prensky, MD
Phone: 717-761-8688
322
mi
from 43215
Camp Hill, PA
Click here to add this to my saved trials
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...
275
mi
from 43215
Charlottesville, VA
Click here to add this to my saved trials
Chesterfield, Missouri 63017
Principal Investigator: Nancy Holekamp, MD
Phone: 636-534-5106
412
mi
from 43215
Chesterfield, MO
Click here to add this to my saved trials
Cleveland, Ohio 44195
Principal Investigator: Rishi Singh, MD
Phone: 216-445-5248
138
mi
from 43215
Cleveland, OH
Click here to add this to my saved trials
Eugene, Oregon 97401
Principal Investigator: Allan Hunter, MD
Phone: 541-762-2763
2055
mi
from 43215
Eugene, OR
Click here to add this to my saved trials
Fort Lauderdale, Florida 33334
Principal Investigator: Darin Goldman, MD
Phone: 954-776-6880
966
mi
from 43215
Fort Lauderdale, FL
Click here to add this to my saved trials
Glendale, California 91203
Principal Investigator: Kent Small, MD
Phone: 818-552-5040
1970
mi
from 43215
Glendale, CA
Click here to add this to my saved trials
Golden, Colorado 80401
Principal Investigator: Brian Joondeph, MD
Phone: 303-261-1600
1174
mi
from 43215
Golden, CO
Click here to add this to my saved trials
Grand Rapids, Michigan
Principal Investigator: Thomas Aaberg, MD
Phone: 616-954-2020
248
mi
from 43215
Grand Rapids, MI
Click here to add this to my saved trials
Hamden, Connecticut 06518
Principal Investigator: David Tom, MD
Phone: 203-288-2020
539
mi
from 43215
Hamden, CT
Click here to add this to my saved trials
Lawrenceville, New Jersey 08648
Principal Investigator: Darma Ie, MD
Phone: 609-896-1414
438
mi
from 43215
Lawrenceville, NJ
Click here to add this to my saved trials
Lexington, Kentucky 40509
Principal Investigator: Rick Isernhagen, MD
Phone: 859-264-2905
154
mi
from 43215
Lexington, KY
Click here to add this to my saved trials
Louisville, Colorado 80027
Principal Investigator: Mary Lansing, MD
Phone: 303-666-1800
1168
mi
from 43215
Louisville, CO
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
Principal Investigator: Abdhish Bhavsar, MD
Phone: 800-233-8504
624
mi
from 43215
Minneapolis, MN
Click here to add this to my saved trials
New York, New York 10021
Principal Investigator: Daniel Rosberger, MD
Phone: 212-439-9600
480
mi
from 43215
New York, NY
Click here to add this to my saved trials
New York, New York 10022
Principal Investigator: K. Bailey Freund, MD
Phone: 212-452-6965
479
mi
from 43215
New York, NY
Click here to add this to my saved trials
New York, New York 10003
Phone: 212-979-4251
442
mi
from 43215
New York, NY
Click here to add this to my saved trials
Northfield, New Jersey
Principal Investigator: Scott Foxman, MD
Phone: 609-646-5200
452
mi
from 43215
Northfield, NJ
Click here to add this to my saved trials
Pensacola, Florida 32514
Principal Investigator: Van Aldred, MD
Phone: 850-969-2560
692
mi
from 43215
Pensacola, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
Principal Investigator: Omesh Gupta, MD
Phone: 215-928-3092
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Principal Investigator: Thomas Friberg, MD
Phone: 412-647-7603
165
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
Poway, California 92064
Principal Investigator: Nikolas London, MD
Phone: 858-451-1911
1938
mi
from 43215
Poway, CA
Click here to add this to my saved trials
Rochester, New York 14618
Principal Investigator: Edward Hall, MD
Phone: 585-442-3411
356
mi
from 43215
Rochester, NY
Click here to add this to my saved trials
4344 Central Avenue North
Saint Petersburg, Florida 33711
Principal Investigator: David Eichenbaum, MD
Phone: 727-323-0077
842
mi
from 43215
Saint Petersburg, FL
Click here to add this to my saved trials
San Antonio, Texas 78240
Principal Investigator: Lina Marouf, MD
Phone: 210-615-7600
1138
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
Toms River, New Jersey 08755
Principal Investigator: Sumit Shah, MD
Phone: 732-797-3984
467
mi
from 43215
Toms River, NJ
Click here to add this to my saved trials
Virginia Beach, Virginia
Principal Investigator: Kapil Kapoor, MD
Phone: 757-481-4400
437
mi
from 43215
Virginia Beach, VA
Click here to add this to my saved trials
Warrenton, Virginia 20186
Principal Investigator: Sam Mansour, MD
Phone: 540-349-1882
292
mi
from 43215
Warrenton, VA
Click here to add this to my saved trials
Washington, District of Columbia 20052
328
mi
from 43215
Washington,
Click here to add this to my saved trials
West Mifflin, Pennsylvania 15122
Principal Investigator: Miguel Busquets, MD
Phone: 412-653-3080
165
mi
from 43215
West Mifflin, PA
Click here to add this to my saved trials
Worcester, Massachusetts 01605
Principal Investigator: Frank McCabe, MD
Phone: 508-752-1155
604
mi
from 43215
Worcester, MA
Click here to add this to my saved trials