Complications of Age-Related Macular Degeneration Prevention Trial
NCT ID: NCT00000167
Last Updated: 2010-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
1052 participants
INTERVENTIONAL
1999-05-31
2006-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prediction of Progression of Age-Related Macular Degeneration
NCT04640649
Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device
NCT02445313
An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration
NCT05300724
Testing Latest Version of NidekRS3000Adv
NCT03318705
Age-Related Macular Degeneration (AMD) - Beta Study Telemedicine Assessment
NCT01083147
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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. A total of 1052 participants were enrolled in the study. Participants 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.
STUDY 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 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 -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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Laser treatment
Low-Intensity Laser Treatment
Initial: 60 barely visible burns, grid pattern. Re-treatment at 12 months: 30 barely visible burns, focal treatment.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Low-Intensity Laser Treatment
Initial: 60 barely visible burns, grid pattern. Re-treatment at 12 months: 30 barely visible burns, focal treatment.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Eye Institute (NEI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
NEI
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stuart L Fine, MD
Role: STUDY_CHAIR
Scheie Eye Institute, The University of Pennsylvania School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Retinal Consultants of Arizona, Ltd.
Mesa, Arizona, United States
Retinal Consultants of Arizona, Ltd.
Peoria, Arizona, United States
West Coast Retina Medical Group, Inc.
San Francisco, California, United States
University of South Florida Eye Institute
Tampa, Florida, United States
Emory Eye Center
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Illinois Retina Associates, S.C.
Harvey, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Ophthalmology & Visual Sciences at the University of Louisville, School of Medicine
Louisville, Kentucky, United States
The Johns Hopkins University
Baltimore, Maryland, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Associate Retinal Consultants, P.C.
Royal Oak, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Barnes Retina Institute
St Louis, Missouri, United States
Retina-Vitreous Center, P.A.
Edison, New Jersey, United States
Retina-Vitreous Center, P.A.
Lakewood, New Jersey, United States
Southeast Clinical Research Associates
Charlotte, North Carolina, United States
Retina Associates of Cleveland
Cleveland, Ohio, United States
The Ohio State University, Department of Ophthalmology
Columbus, Ohio, United States
Casey Eye Institute
Portland, Oregon, United States
Retina Northwest, P.C.
Portland, Oregon, United States
Scheie Eye Institute
Philadelphia, Pennsylvania, United States
Texas Retina Associates
Dallas, Texas, United States
University of Wisconsin - Madison, Department of Ophthalmology and Visual Sciences
Madison, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Brader HS, Ying GS, Martin ER, Maguire MG; Complications of Age-Related Macular Degeneration Prevention Trial-CAPT Research Group. New grading criteria allow for earlier detection of geographic atrophy in clinical trials. Invest Ophthalmol Vis Sci. 2011 Nov 29;52(12):9218-25. doi: 10.1167/iovs.11-7493.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NEI-70
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.