Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
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|ClinicalTrials.gov Identifier: NCT00548197|
Recruitment Status : Unknown
Verified October 2007 by Iran University of Medical Sciences.
Recruitment status was: Recruiting
First Posted : October 23, 2007
Last Update Posted : October 23, 2007
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.
|Condition or disease||Intervention/treatment||Phase|
|Intravitreal Bevacizumab Injection Pars Plana Vitrectomy Tractional Retinal Detachment Diabetic Retinopathy||Drug: Bevacizumab||Phase 1|
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)
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment|
|Study Start Date :||February 2007|
|Estimated Study Completion Date :||December 2007|
Intravitreal Bevacizumab will be injected in this group before performing pars plana vitrectomy
one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
Other Name: Brand name of Bevacizumab is Avastin
- Best corrected visual acuity [ Time Frame: last follow up ]
- Anatomic status of the retina [ Time Frame: Last follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00548197
|Contact: Mehdi Modarres, MDemail@example.com|
|Iran, Islamic Republic of|
|Rasool Akram Hospital||Recruiting|
|Tehran, Iran, Islamic Republic of, 14455-364|
|Study Director:||Mehdi Modarres, MD||Iran University of Medical Sciences(IUMS)|