Nctid:
NCT00000167
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D008268", "term"=>"Macular Degeneration"}], "ancestors"=>[{"id"=>"D012162", "term"=>"Retinal Degeneration"}, {"id"=>"D012164", "term"=>"Retinal Diseases"}, {"id"=>"D005128", "term"=>"Eye Diseases"}], "browseLeaves"=>[{"id"=>"M11260", "name"=>"Macular Degeneration", "asFound"=>"Macular Degeneration", "relevance"=>"HIGH"}, {"id"=>"M14997", "name"=>"Retinal Degeneration", "relevance"=>"LOW"}, {"id"=>"M14999", "name"=>"Retinal Diseases", "relevance"=>"LOW"}, {"id"=>"M8271", "name"=>"Eye Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Eye Diseases", "abbrev"=>"BC11"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>1052}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1999-05"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2007-12", "completionDateStruct"=>{"date"=>"2006-06", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2010-03-23", "studyFirstSubmitDate"=>"1999-09-23", "studyFirstSubmitQcDate"=>"1999-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2010-03-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-09-24", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Change in visual acuity (3-line loss)", "timeFrame"=>"5 years"}], "secondaryOutcomes"=>[{"measure"=>"Incidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy", "timeFrame"=>"5 years"}, {"measure"=>"Changes in contrast threshold and critical print size for reading", "timeFrame"=>"5 years"}]}, "oversightModule"=>{"oversightHasDmc"=>true}, "conditionsModule"=>{"keywords"=>["Age-Related Macular Degeneration"], "conditions"=>["Macular Degeneration"]}, "referencesModule"=>{"references"=>[{"pmid"=>"22039251", "type"=>"DERIVED", "citation"=>"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."}]}, "descriptionModule"=>{"briefSummary"=>"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.", "detailedDescription"=>"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.\n\nThe 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.\n\nFurther 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.\n\nThe 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:\n\nChange in visual acuity (primary outcome measure of the study)\n\nIncidence of complications of AMD such as neovascularization, serous detachment of the pigment epithelium, and geographic atrophy\n\nChanges in contrast threshold and critical print size for reading\n\nQuality of life assessments for patients, using the Visual Function Questionnaire 25 (VFQ-25), were conducted at the time of enrollment and at 5 years.\n\nSTUDY RESULTS:\n\nFollow-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.\n\nAs applied in CAPT, low intensity laser treatment did not demonstrate a clinically significant benefit on vision in eyes of people with bilateral large drusen."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"50 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Patients eligible for CAPT can be either male or female and meet the following criteria:\n\nAge at least 50 years old\n\nVision in each eye must measure 20/40 or better.\n\nAt least 10 large drusen in each eye\n\nAvailable for follow-up examinations for 5 years after enrollment\n\nFinal eligibility is determined through a detailed eye examination by a CAPT-certified ophthalmologist."}, "identificationModule"=>{"nctId"=>"NCT00000167", "acronym"=>"CAPT", "briefTitle"=>"Complications of Age-Related Macular Degeneration Prevention Trial", "organization"=>{"class"=>"NIH", "fullName"=>"National Eye Institute (NEI)"}, "officialTitle"=>"Complications of Age-Related Macular Degeneration Prevention Trial (CAPT)", "orgStudyIdInfo"=>{"id"=>"NEI-70"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"1", "description"=>"Laser treatment", "interventionNames"=>["Procedure: Low-Intensity Laser Treatment"]}], "interventions"=>[{"name"=>"Low-Intensity Laser Treatment", "type"=>"PROCEDURE", "description"=>"Initial: 60 barely visible burns, grid pattern. Re-treatment at 12 months: 30 barely visible burns, focal treatment.", "armGroupLabels"=>["1"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85201", "city"=>"Mesa", "state"=>"Arizona", "country"=>"United States", "facility"=>"Retinal Consultants of Arizona, Ltd.", "geoPoint"=>{"lat"=>33.42227, "lon"=>-111.82264}}, {"zip"=>"85351", "city"=>"Peoria", "state"=>"Arizona", "country"=>"United States", "facility"=>"Retinal Consultants of Arizona, Ltd.", "geoPoint"=>{"lat"=>33.5806, "lon"=>-112.23738}}, {"zip"=>"94107", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"West Coast Retina Medical Group, Inc.", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"33612-4766", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"University of South Florida Eye Institute", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"30322", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Emory Eye Center", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern University", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60426", "city"=>"Harvey", "state"=>"Illinois", "country"=>"United States", "facility"=>"Illinois Retina Associates, S.C.", "geoPoint"=>{"lat"=>41.61003, "lon"=>-87.64671}}, {"zip"=>"55242-1091", "city"=>"Iowa City", "state"=>"Iowa", "country"=>"United States", "facility"=>"University of Iowa", "geoPoint"=>{"lat"=>41.66113, "lon"=>-91.53017}}, {"zip"=>"40202-1594", "city"=>"Louisville", "state"=>"Kentucky", "country"=>"United States", "facility"=>"Ophthalmology & Visual Sciences at the University of Louisville, School of Medicine", "geoPoint"=>{"lat"=>38.25424, "lon"=>-85.75941}}, {"zip"=>"21287-9223", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"The Johns Hopkins University", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Ophthalmic Consultants of Boston", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"48073", "city"=>"Royal Oak", "state"=>"Michigan", "country"=>"United States", "facility"=>"Associate Retinal Consultants, P.C.", "geoPoint"=>{"lat"=>42.48948, "lon"=>-83.14465}}, {"zip"=>"55905", "city"=>"Rochester", "state"=>"Minnesota", "country"=>"United States", "facility"=>"Mayo Clinic", "geoPoint"=>{"lat"=>44.02163, "lon"=>-92.4699}}, {"zip"=>"63110", "city"=>"St. Louis", "state"=>"Missouri", "country"=>"United States", "facility"=>"Barnes Retina Institute", "geoPoint"=>{"lat"=>38.62727, "lon"=>-90.19789}}, {"zip"=>"08820", "city"=>"Edison", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Retina-Vitreous Center, P.A.", "geoPoint"=>{"lat"=>40.51872, "lon"=>-74.4121}}, {"zip"=>"08701", "city"=>"Lakewood", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Retina-Vitreous Center, P.A.", "geoPoint"=>{"lat"=>40.09789, "lon"=>-74.21764}}, {"zip"=>"28204", "city"=>"Charlotte", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Southeast Clinical Research Associates", "geoPoint"=>{"lat"=>35.22709, "lon"=>-80.84313}}, {"zip"=>"44122", "city"=>"Cleveland", "state"=>"Ohio", "country"=>"United States", "facility"=>"Retina Associates of Cleveland", "geoPoint"=>{"lat"=>41.4995, "lon"=>-81.69541}}, {"zip"=>"43210", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"The Ohio State University, Department of Ophthalmology", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"97201-4197", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Casey Eye Institute", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"97210", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Retina Northwest, P.C.", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Scheie Eye Institute", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"75231", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Texas Retina Associates", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"53705", "city"=>"Madison", "state"=>"Wisconsin", "country"=>"United States", "facility"=>"University of Wisconsin - Madison, Department of Ophthalmology and Visual Sciences", "geoPoint"=>{"lat"=>43.07305, "lon"=>-89.40123}}], "overallOfficials"=>[{"name"=>"Stuart L Fine, MD", "role"=>"STUDY_CHAIR", "affiliation"=>"Scheie Eye Institute, The University of Pennsylvania School of Medicine"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Eye Institute (NEI)", "class"=>"NIH"}, "responsibleParty"=>{"oldNameTitle"=>"Natalie Kurinij", "oldOrganization"=>"NEI"}}}}
