Diabetic Retinopathy Clinical Trial
Official title:
Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment
NCT number | NCT00548197 |
Other study ID # | 85-A-57 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | February 2007 |
Est. completion date | March 2008 |
Verified date | February 2007 |
Source | Iran University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | March 2008 |
Est. primary completion date | February 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Rasool Akram Hospital | Tehran |
Lead Sponsor | Collaborator |
---|---|
Iran University of Medical Sciences |
Iran, Islamic Republic of,
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. — View 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. — View Citation
Spaide RF, Fisher YL. Intravitreal bevacizumab (Avastin) treatment of proliferative diabetic retinopathy complicated by vitreous hemorrhage. Retina. 2006 Mar;26(3):275-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Best Corrected Visual Acuity | Post operative best corrected visual acuity ( best distance vision with eyeglasses or contact lenses) | last follow up, an average of 7 months post-operation | |
Secondary | Anatomic Status of the Retina | Number of Participants with Postoperative Vitreous Hemorrhage | Last follow up, an average of 7 months post-operation |
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