Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
Primary Purpose
Intravitreal Bevacizumab Injection, Pars Plana Vitrectomy, Tractional Retinal Detachment
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Intravitreal Bevacizumab Injection focused on measuring Intravitreal Bevacizumab injection, Pars plana vitrectomy, tractional retinal detachment, Diabetic retinopathy
Eligibility 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.
Sites / Locations
- Rasool Akram Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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
no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
Outcomes
Primary Outcome Measures
Best Corrected Visual Acuity
Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)
Secondary Outcome Measures
Anatomic Status of the Retina
Number of Participants with Postoperative Vitreous Hemorrhage
Full Information
NCT ID
NCT00548197
First Posted
October 22, 2007
Last Updated
October 13, 2018
Sponsor
Iran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00548197
Brief Title
Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
Official Title
Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iran University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intravitreal Bevacizumab Injection, Pars Plana Vitrectomy, Tractional Retinal Detachment, Diabetic Retinopathy
Keywords
Intravitreal Bevacizumab injection, Pars plana vitrectomy, tractional retinal detachment, Diabetic retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Brand name of Bevacizumab is Avastin
Intervention Description
one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses)
Time Frame
last follow up, an average of 7 months post-operation
Secondary Outcome Measure Information:
Title
Anatomic Status of the Retina
Description
Number of Participants with Postoperative Vitreous Hemorrhage
Time Frame
Last follow up, an average of 7 months post-operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehdi Modarres, MD
Organizational Affiliation
Iran University of Medical Sciences(IUMS)
Official's Role
Study Director
Facility Information:
Facility Name
Rasool Akram Hospital
City
Tehran
ZIP/Postal Code
14455-364
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
16508426
Citation
Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. doi: 10.1097/00006982-200603000-00004.
Results Reference
background
PubMed Identifier
12598446
Citation
Castellarin A, Grigorian R, Bhagat N, Del Priore L, Zarbin MA. Vitrectomy with silicone oil infusion in severe diabetic retinopathy. Br J Ophthalmol. 2003 Mar;87(3):318-21. doi: 10.1136/bjo.87.3.318.
Results Reference
background
PubMed Identifier
16815268
Citation
Grisanti S, Biester S, Peters S, Tatar O, Ziemssen F, Bartz-Schmidt KU; Tuebingen Bevacizumab Study Group. Intracameral bevacizumab for iris rubeosis. Am J Ophthalmol. 2006 Jul;142(1):158-60. doi: 10.1016/j.ajo.2006.02.045.
Results Reference
background
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Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
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