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Trial NCT00000154

Resource URI: http://static.linkedct.org/resource/trials/NCT00000154
linkedct:brief_title Diabetic Retinopathy Vitrectomy Study (DRVS)
linkedct:condition <http://static.linkedct.org/resource/condition/11555>
linkedct:condition <http://static.linkedct.org/resource/condition/13861>
linkedct:condition <http://static.linkedct.org/resource/condition/3876>
linkedct:criteria Men and women eligible for the vitreous hemorrhage group had at least one eye with recent severe vitreous hemorrhage (within 5 months) and visual acuity of 5/200 or less. Patients eligible for the "very severe proliferative retinopathy with useful vision" group had extensive active fibrovascular proliferations and visual acuity of 10/200 or better.
linkedct:description Vitrectomy may not only remove vitreous hemorrhage but also prevent or relieve traction on the retina from contraction of the fibrovascular membranes that characterize severe proliferative diabetic retinopathy. It is important to determine whether early intervention with vitrectomy has a better visual outcome or instead produces a rate of serious complications higher than the rate associated with conventional management. Two randomized trials were carried out in the DRVS among patients ages 18 to 70 years who had either insulin-dependent or non-insulin-dependent diabetes. In the first trial, the 616 patients who were recruited had severe visual loss from recent severe vitreous hemorrhage in at least one eye. Eligible eyes were randomly assigned either to early vitrectomy or to conventional management. In the conventional management group, vitrectomy was carried out 1 year later if hemorrhage persisted; vitrectomy was carried out sooner if retinal detachment -involving the center of the macula occurred. In the second trial, 381 patients were recruited, all of whom had severe fibrovascular proliferations and useful vision in at least one eye. Eligible eyes were assigned either to early vitrectomy or to conventional management. Conventional management included photocoagulation when indicated, with vitrectomy if a severe vitreous hemorrhage occurred and failed to clear spontaneously during a 6-month waiting period or if retinal detachment involving the center of the macula -occurred. After randomization and treatment, all patients were examined at 6-month intervals for 2 years and annually thereafter. Comparisons of visual acuity distributions between experimental and control groups were made.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 70 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date September 23, 1999
linkedct:id NCT00000154
rdfs:label Trial NCT00000154
linkedct:lastchanged_date June 23, 2005
linkedct:lead_sponsor_agency National Eye Institute (NEI)
linkedct:nct_id NCT00000154
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NEI-56
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000154>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/38425>
linkedct:reference <http://static.linkedct.org/resource/reference/39179>
linkedct:reference <http://static.linkedct.org/resource/reference/39180>
linkedct:reference <http://static.linkedct.org/resource/reference/39970>
linkedct:reference <http://static.linkedct.org/resource/reference/42176>
linkedct:source National Eye Institute (NEI)
linkedct:start_date October 1976
linkedct:study_design Treatment, Randomized
linkedct:study_type Interventional
linkedct:summary To compare two therapies, early vitrectomy and conventional management, for recent severe vitreous hemorrhage secondary to diabetic retinopathy. Conventional management includes vitrectomy if hemorrhage fails to clear during a waiting period of 6 to 12 months or if retinal detachment involving the center of the macula develops at any time. To compare early vitrectomy and conventional management in eyes that have good vision but a poor prognosis because they are threatened with hemorrhage or retinal detachment from very severe proliferative retinopathy. To study the natural history of severe proliferative diabetic retinopathy.
rdf:type linkedct:trials
linkedct:verification_date October 1999