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Trial NCT00548197

Resource URI: http://static.linkedct.org/resource/trials/NCT00548197
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/30939>
linkedct:brief_title Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
linkedct:condition <http://static.linkedct.org/resource/condition/13157>
linkedct:condition <http://static.linkedct.org/resource/condition/3876>
linkedct:condition <http://static.linkedct.org/resource/condition/6824>
linkedct:condition <http://static.linkedct.org/resource/condition/9713>
linkedct:criteria Inclusion Criteria: - Those patients with tractional retinal detachment who are candidated for pars plana vitrectomy. - Complexity score between 4 and 8. Exclusion Criteria: - Previous vitreoretinal surgery. - Presence of any other vitreoretinal pathology such as past or present uveitis, and retinal artery or vein occlusion.
linkedct:description Eligibility criteria: Diabetic tractional retinal detachment-complexity score between 4 and 8 Main outcome measures: best corrected visual acuity-anatomic condition of the retine(re-attachment of the retina)
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 90 Years
linkedct:eligibility_minimum_age 18 Years
linkedct:end_date December 2007
linkedct:enrollment 50 (xsd:int)
linkedct:firstreceived_date October 22, 2007
linkedct:has_dmc No
linkedct:id NCT00548197
linkedct:intervention <http://static.linkedct.org/resource/intervention/60036>
rdfs:label Trial NCT00548197
linkedct:lastchanged_date October 22, 2007
linkedct:lead_sponsor_agency Iran University of Medical Sciences
linkedct:location <http://static.linkedct.org/resource/location/73052>
linkedct:nct_id NCT00548197
linkedct:number_of_arms 1 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
linkedct:org_study_id 85-A-57
linkedct:overall_contact_email modarreszif@yahoo.com
linkedct:overall_contact_last_name Mehdi Modarres, MD
linkedct:overall_contact_phone 00989121266221
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/40015>
linkedct:overall_status Recruiting
linkedct:oversight <http://static.linkedct.org/resource/oversight/1388>
foaf:page <http://clinicaltrials.gov/show/NCT00548197>
linkedct:phase Phase 1
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/66327>
linkedct:reference <http://static.linkedct.org/resource/reference/16423>
linkedct:reference <http://static.linkedct.org/resource/reference/30188>
linkedct:reference <http://static.linkedct.org/resource/reference/31388>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/8349>
linkedct:source Iran University of Medical Sciences
linkedct:start_date February 2007
linkedct:study_design Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
linkedct:study_type Interventional
linkedct:summary Vitreoretinal surgery for epiretinal proliferation tractional retinal detachment associated with proliferative diabetic retinopathy (PDR) is often complicated by hemorrhage from fibrovascular tissue. To control the bleeding during tissue dissection multiple measures and techniques are used. Bevacizumab is an anti VEGF antibody which has been used to induce regression of ocular neovascularization. Its intraocular injection has been increasingly used for treatment of choroidal neovascularization (CNV) associated with age related macular degeneration (AMD) with fairly good success.Also it has been shown to be effective for treatment of PDR complicated with vitreous hemorrhage and iris neovascularization. We hypothesized that if anti-angiogenic agents, such as bevacizumab are injected into the vitreous cavity before vitrectomy in cases of PDR; there may be partial regression of neovascularization resulting in less intraoperative (and postoperative) hemorrhage. This can make the operation easier and shorter and lessen the need for intraocular cautery.. In this study diabetic patients who are candidated for vitrectomy with similar complexity scores will be randomized to preoperative injection or no injection of 2.5 mg Bevacizumab .In the injection group, 2.5 mg of bevacizumab (0.1 ml of commercially available Avastin vial, Genentech, inc. South San Francisco, CA) will be injected into the vitreous 3-5 days before operation. During each operation, the number of endodiathermy applications, backflush needle applications and the duration of surgery will be recorded by an independent observer. Also, type of tamponade, post operation vitreous hemorrhage and 3 months postoperative visual acuities wil be recorded. all these parameters will be compared in two groups.
rdf:type linkedct:trials
linkedct:verification_date October 2007