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Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
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Purpose | Background | Description | Patient
Eligibility | Patient Recruitment Status | Current
Status of Study | Results | Publications | Clinical Centers | NEI Representative | Resource Centers |
Purpose:
To determine whether application of low-intensity laser treatment of eyes with drusen in the macula can prevent later complications of age-related macular degeneration and thereby preserve visual function.
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Background:
Complications of age-related macular degeneration (AMD) are the leading cause of severe vision loss among people aged 65 and over in the United States and many Western countries. Most, (approximately 90 percent), of this vision loss is due to the neovascular (or wet) form of AMD. The word neovascular describes the development of new, abnormal blood vessels in the back of the eye. Unfortunately, the majority of these new vessels are not amenable to currently available treatments.
The first sign that an eye may develop AMD is the presence of drusen, yellowish deposits under the retina. Current data suggests that eyes with large drusen are at increased risk for developing the vision threatening complications of AMD. Since the 1970s investigators have reported consistently that laser photocoagulation causes a reduction in large drusen. However, results of the effects of laser treatment on preventing later complications of AMD have been less consistent and based on relatively small numbers of patients.
Further study into the ability of a treatment to prevent vision loss from the advanced forms of AMD would have profound public health implications. A treatment that could reduce the risk of developing neovascularization by 30 percent might reduce the risk of blindness from AMD by one half. The Complications of Age-related Macular Degeneration Prevention Trial (CAPT) will assess whether treating drusen by laser photocoagulation reduces the risk of loss of visual acuity.
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Description:
The CAPT is a multi-center, prospective, randomized clinical trial designed to assess the safety and effectiveness of low-intensity laser treatment in preventing vision loss among patients with large drusen in both eyes. Eligible patients had one eye randomly assigned to laser treatment performed by a CAPT-certified ophthalmologist. The other eye was not treated. Both eyes were observed carefully for any changes for a period of five years. The effectiveness of the treatment was assessed using the following criteria:
- Change in visual acuity (primary outcome measure of the study)
- Incidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy
- Changes in contrast threshold and critical print size for reading
Quality of life assessments for patients, using the Visual Function Questionnaire 25 (VFQ-25), were conducted at the time of enrollment and at 5 years.
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Patient Eligibility:
Patients eligible for CAPT can be either male or female and meet the following criteria:
- Age at least 50 years old
- Vision in each eye must measure 20/40 or better.
- At least 10 large drusen in each eye
- Available for follow-up examinations for 5 years after enrollment
Final eligibility was determined through a detailed eye examination by a CAPT-certified ophthalmologist.
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Patient Recruitment Status:
No longer recruiting. Comments: Completed. A total of 1,052 were enrolled at 22 clinical centers across the United States. Recruitment began on May 1, 1999 and ended on March 31, 2001. Participants were followed for a minimum of 5 years.
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Current Status of Study:
Completed, with results published. Comments:
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Results:
Follow-up of patients was excellent; less than 3% of visual acuity examinations were missed. At 5 years, 188 (20.5%) treated eyes and 188 (20.5%) observed eyes had visual acuity scores 3 or more lines worse than at the initial visit (p= 1.00). The cumulative 5-year incidence rates for treated and observed eyes for CNV were 13.3% and 13.3% (p=0.95), respectively; and for GA were 7.4% and 7.8% (p=0.64), respectively. The contrast threshold doubled in 23.9% of treated eyes and in 20.5% of observed eyes (p=0.40). The critical print size doubled in 29.6% of treated eyes and in 28.4% of observed eyes (p=0.70). Seven (0.7%) treated eyes and 14 (1.3%) observed eyes had an adverse event of a 6 or more line loss in visual acuity in the absence of late age-related macular degeneration or cataract.
As applied in CAPT, low intensity laser treatment did not demonstrate a clinically significant benefit on vision in eyes of people with bilateral large drusen.
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Publications
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Complications of Age-related Macular Degeneration Prevention Trial Research Group: Laser treatment in patients with bilateral large drusen: The Complications of Age-Related Macular Degeneration Prevention Trial. Ophthalmology 113: 1974-1986, 2006
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Complications of Age-related Macular Degeneration Prevention Trial Research Group: The Complications of Age-related Macular Degeneration Prevention Trial (CAPT): Rationale, design and methodology. Clinical Trials 1: 1-17, 2004
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Complications of Age-related Macular Degeneration Prevention Trial Research Group: Baseline characteristics, the NEI-VFQ-25, and their associations in the Complications of Age-related Macular Degeneration Prevention Trial (CAPT). Ophthalmology 111: 1307-1316, 2004
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Clinical Centers
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Arizona Donald W. Park, M.D. Retinal Consultants of Arizona, Ltd. 2152 S. Vineyard Building 12, Suite 139 Mesa, AZ 85210 USA Telephone: (480) 833-7898 Fax: (480) 833-6209
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Arizona Donald W. Park, M.D. Retinal Consultants of Arizona, Ltd. 13943 N. 91st Avenue Building D Peoria, AZ 85351 USA Telephone: (602) 222-2221 Fax: (602) 222-9361
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California Robert M. Johnson, M.D. West Coast Retina Medical Group, Inc. 185 Berry Street, Suite 130 San Francisco, CA 94107-1739 USA Telephone: (415) 972-4600 Fax: (415) 975-0999
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Florida Peter Reed Pavan, M.D. University of South Florida Eye Institute 12901 Bruce B. Downs Boulevard MDC Box 21 Tampa, FL 33612-4766 USA Telephone: (813) 974-1530 Fax: (813) 974-5621
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Georgia Baker Hubbard, III M.D. Emory Eye Center Emory University School of Medicine 1365-B Clifton Road, 4th Floor, Room B4625 Atlanta, GA 30322 USA Telephone: (404) 778-3245 Fax: (404) 778-5128
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Illinois Alice Lyon, M.D. Northwestern University, Ophthalmology Dept. 675 N. St. Clair Street Galter Pavilion, 15th floor Chicago, IL 60611 USA Telephone: (312) 695-2567 Fax: (312) 695-3111
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Illinois David Orth, M.D. Illinois Retina Associates, S.C. Irwin Retina Center 71 West 156th Street, Suite 400 Harvey, IL 60426 USA Telephone: (708) 915-6927 Fax: (708) 596-9820
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Iowa James Folk, M.D. University of Iowa Department of Ophthalmology and Visual Sciences 200 Hawkins Drive Iowa City, IA 55242-1091 USA Telephone: (319) 356-4338 Fax: (319) 356-0363
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Kentucky Charles C. Barr, M.D. Ophthalmology & Visual Sciences at the University of Louisville School of Medicine Kentucky Lions Eye Research Institute 301 East Muhammad Ali Boulevard Louisville, KY 40202-1594 USA Telephone: (502) 852-7387 Fax: (502) 852-7298
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Maryland Susan B. Bressler, M.D. The Johns Hopkins University Wilmer Ophthalmological Institute Johns Hopkins Hospital, Maumanee 713 600 North Wolfe Street Baltimore, MD 21287-9223 USA Telephone: (410) 614-6908 Fax: (410) 614-1683
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Massachusetts Jeffrey Heier, M.D. Ophthalmic Consultants of Boston Diseases and Surgery of the Retina and Vitreous 50 Staniford Street, Suite 600 Boston, MA 02114 USA Telephone: (617) 367-4800 Fax: (617) 723-7028
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Michigan Michael Trese, M.D. Associate Retinal Consultants, P.C. William Beaumont Hospital 3535 West Thirteen Mile Road, Suite 636 Royal Oak, MI 48073 USA Telephone: (248) 551-9866 Fax: (248) 551-3877
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Minnesota Colin A. McCannel, M.D. Mayo Clinic 200 First Street, S.W. Rochester, MN 55905 USA Telephone: (507) 284-5052 Fax: (507) 284-4612
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Missouri Gilbert Grand, M.D. Barnes Retina Institute 1 Barnes Hospital Plaza Suite 17413 East Pavilion St. Louis, MO 63110 USA Telephone: (314) 367-1278 Fax: (314) 367-5764
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New Jersey Steven R. Leff, M.D. Retina-Vitreous Center, P.A. 98 James Street, Suite 310 Edison, NJ 08820 USA Telephone: (732) 363-3891 Fax: (732) 363-0403
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New Jersey Steven R. Leff, M.D. Retina-Vitreous Center, P.A. 525 Route 70 West, Suite B-14 Lakewood, NJ 08701 USA Telephone: (732) 363-3891 Fax: (732) 363-0403
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North Carolina Andrew N. Antoszyk, M.D. Southeast Clinical Research Associates 6035 Fairview Road Charlotte, NC 28210 USA Telephone: (704) 295-3390 Fax: (704) 295-3395
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Ohio Frederick H. Davidorf, M.D. The Ohio State University Medical Center Retinal Consultants, Inc. 456 West 10th Avenue, Suite 5B Columbus, OH 43210 USA Telephone: (614) 293-8041 Fax: (614) 293-6180
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Ohio Lawrence J. Singerman, M.D. Retina Associates of Cleveland 3401 Enterprise Parkway, Suite 300 Cleveland, OH 44122 USA Telephone: (800) 473-8462 Fax: (216) 360-2196
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Oregon Michael L. Klein, M.D. Casey Eye Institute 3375 S.W. Terwillager Boulevard Portland, OR 97201-4197 USA Telephone: (503) 494-3055 Fax: (503) 494-7233
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Oregon Richard F. Dreyer, M.D. Retina Northwest, P.C. 2525 NW Lovejoy Ave., Suite 100 Portland, OR 97210 USA Telephone: (503) 271-2121 Fax: (503) 725-1734
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Pennsylvania Juan E. Grunwald, M.D. Scheie Eye Institute 51 North 39th Street, Room 501 Philadelphia, PA 19104 USA Telephone: (215) 662-8691 Fax: (215) 662-8025
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Texas Gary Edd Fish, M.D. Texas Retina Associates 7150 Greenville Avenue, Suite 400 Dallas, TX 75231 USA Telephone: (214) 692-6941 Fax: (214) 739-5797
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Wisconsin Suresh R. Chandra, M.D. University of Wisconsin - Madison Department of Ophthalmology and Visual Sciences 2880 University Avenue, Room 224 Madison, WI 53705 USA Telephone: (608) 263-7171 Fax: (608) 262-6222
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NEI Representative
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Natalie Kurinij, Ph.D. National Eye Institute National Institutes of Health 5635 Fishers Lane, MSC 9300 Suite 1300 Bethesda, MD 20892-9300 USA Telephone: (301) 451-2020 Fax: (301) 402-0528
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Resource Centers
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Chairman’s Office Stuart L. Fine, M.D. Scheie Eye Institute The University of Pennsylvania School of Medicine Department of Ophthalmology 51 N. 39th Street Philadelphia, PA 19104 USA Telephone: (215) 662-8142
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Coordinating Center Maureen G. Maguire, Ph.D., Director CAPT Coordinating Center 3535 Market Street, Suite 700 Philadelphia, PA 19104-3309 USA Telephone: (215) 615-1500 Fax: (215) 615-1531
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Photograph Reading Center Judy Alexander, Director CAPT Photograph Reading Center 3535 Market Street, Suite 700 Philadelphia, PA 19104-3309 USA Telephone: (215) 615-1515 Fax: (215) 615-1533
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Last Updated: 11/1/2006 |
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