Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
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StatusCompleted
Sponsors
Iran University of Medical Sciences
CLINICAL TRIAL: NCT00548197
BioSeek: nct00548197
Keywords
Abstract
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.
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)
Dates
| Last Verified: | 01/31/2007 |
| First Submitted: | 10/21/2007 |
| Estimated Enrollment Submitted: | 10/21/2007 |
| First Posted: | 10/22/2007 |
| Last Update Submitted: | 10/12/2018 |
| Last Update Posted: | 10/15/2018 |
| Date of first submitted results: | 02/28/2018 |
| Date of first submitted QC results: | 10/12/2018 |
| Date of first posted results: | 10/15/2018 |
| Actual Study Start Date: | 01/31/2007 |
| Estimated Primary Completion Date: | 01/31/2008 |
| Estimated Study Completion Date: | 02/29/2008 |
Condition or disease
Intravitreal Bevacizumab Injection
Pars Plana Vitrectomy
Tractional Retinal Detachment
Diabetic Retinopathy
Intervention/treatment
Drug: Intervention group
Phase
Phase 1
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Intervention group Intravitreal Bevacizumab will be injected 2.5 mg IVB 3-5 days before operation in diabetic patients who were candidates for vitrectomy before performing pars plana vitrectomy | Drug: Intervention group one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy |
| No Intervention: Control group no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Best Corrected Visual Acuity [last follow up, an average of 7 months post-operation]
Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)
Secondary Outcome Measures
1. Anatomic Status of the Retina [Last follow up, an average of 7 months post-operation]
Number of Participants with Postoperative Vitreous Hemorrhage
