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Home > "C" Clinical Trials Conditions > Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)  Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
For Condition: Macular Degeneration
Status: No longer recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: 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.
Details: 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. 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 will have one eye randomly assigned to laser treatment performed by a CAPT-certified ophthalmologist. The other eye is not treated. Both eyes are observed carefully for any changes for a period of five years. The effectiveness of the treatment will be 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), will be conducted at the time of enrollment and at 5 years.
Eligibility:
Study Type: Interventional, Prevention, Randomized
Minimum Age/Maximum Age: 50 Years/
Genders: Both
Protocol Entry Criteria: 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 is determined through a detailed eye examination by a CAPT-certified ophthalmologist.
Total Enrollment:
Location and Contact Information:
Scheie Eye Institute
Philadelphia, Pennsylvania, 19104
United States
Barnes Retina Institute
St. Louis, Missouri, 63110
United States
Retina-Vitreous Center, P.A.
Lakewood, New Jersey, 08701
United States
Retina Associates of Cleveland
Cleveland, Ohio, 44122
United States
Retina-Vitreous Center, P.A.
Edison, New Jersey, 08820
United States
Schatz, McDonald, Johnson, Ai
San Francisco, California, 94109
United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
United States
Texas Retina Associates
Dallas, Texas, 75231
United States
Retinal Consultants of Arizona, Ltd.
Sun City, Arizona, 85351
United States
Ophthalmology & Visual Sciences at the University of Louisville, School of Medicine
Louisville, Kentucky, 40202-1594
United States
Private Practice
Portland, Oregon, 97210
United States
The Johns Hopkins University
Baltimore, Maryland, 21287-9223
United States
Charlotte Eye, Ear, Nose and Throat Associates, P.A.
Charlotte, North Carolina, 28204
United States
Illinois Retina Associates, S.C.
Harvey, Illinois, 60426
United States
The Ohio State University, Department of Ophthalmology
Columbus, Ohio, 43210
United States
Casey Eye Institute
Portland, Oregon, 97201-4197
United States
University of South Florida Eye Institute
Tampa, Florida, 33612-4766
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Wisconsin - Madison, Department of Ophthalmology and Visual Sciences
Madison, Wisconsin, 53705
United States
Retinal Consultants of Arizona, Ltd.
Mesa, Arizona, 85201
United States
University of Iowa
Iowa City, Iowa, 55242-1091
United States
Emory Eye Center
Atlanta, Georgia, 30322
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Associate Retinal Consultants, P.C.
Royal Oak, Michigan, 48073
United States
Additional Information:
Study ID Numbers: NEI-70;
Study Start Date: May 1999
Record last reviewed: November 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000167
Other Macular Degeneration Studies:
1. Randomized Trials of Vitamin Supplements and Eye Disease
2. Lutein for Age-Related Macular Degeneration
3. Phase I Study of Corticosteroid Treatment of Ill-defined Choroidal Neovascularization in Age-related Macular Degeneration
4. Fluocinolone Implant to Treat Macular Degeneration
5. Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
Related Studies:
Other Macular Degeneration Clinical Trials
Other Oregon Clinical Trials
Other Portland Clinical Trials
Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)
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