Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
Information source: Iran University of Medical Sciences
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intravitreal Bevacizumab Injection; Pars Plana Vitrectomy; Tractional Retinal Detachment; Diabetic Retinopathy
Intervention: Bevacizumab (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Iran University of Medical Sciences Official(s) and/or principal investigator(s):
Mehdi Modarres, MD, Study Director, Affiliation: Iran University of Medical Sciences(IUMS)
Overall contact:
Mehdi Modarres, MD, Phone: 00989121266221, Email: modarreszif@yahoo.com
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.
Clinical Details
Official title: Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Best corrected visual acuity
Secondary outcome: Anatomic status of the retina
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)
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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.
Locations and Contacts
Mehdi Modarres, MD, Phone: 00989121266221, Email: modarreszif@yahoo.com
Rasool Akram Hospital, Tehran 14455-364, Iran, Islamic Republic of; Recruiting
Additional Information
Related publications: Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. 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. 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.
Starting date: February 2007
Ending date: December 2007
Last updated: October 22, 2007
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