Clinical trial NCT00548197: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Intravitreal Bevacizumab Injection
Pars Plana Vitrectomy
Tractional Retinal Detachment
Diabetic Retinopathy
Keywords: Intravitreal Bevacizumab injection
Pars plana vitrectomy
tractional retinal detachment
Diabetic retinopathy
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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.

Primary outcomes:
measure: Best Corrected Visual Acuity
timeFrame: last follow up, an average of 7 months post-operation
Secondary outcomes:
measure: Anatomic Status of the Retina
timeFrame: Last follow up, an average of 7 months post-operation
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Rasool Akram Hospital
Study officials:
affiliation: Iran University of Medical Sciences(IUMS)
name: Mehdi Modarres, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.