Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment

NCT00548197 | Completed Phase 1 Results

• 1 other identifier: 85-A-57
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravitreal Bevacizumab Injection; Pars Plana Vitrectomy; Tractional Retinal Detachment; Diabetic Retinopathy

Keywords

Intravitreal Bevacizumab injection; Pars plana vitrectomy; tractional retinal detachment; Diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Anatomic Status of the Retina

  Last follow up, an average of 7 months post-operation

Study Arms (2)

Intervention group

EXPERIMENTAL

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: Bevacizumab

Control group

NO INTERVENTION

no injection before performing pars plana vitrectomy in diabetic patients who were candidates for vitrectomy

Interventions

Bevacizumab DRUG

one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy

Also known as: Brand name of Bevacizumab is Avastin

Intervention group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those patients with tractional retinal detachment who are candidated for pars plana vitrectomy.
• Complexity score between 4 and 8.

You may not qualify if:

• Previous vitreoretinal surgery.
• Presence of any other vitreoretinal pathology such as past or present uveitis, and retinal artery or vein occlusion.

Sponsors & Collaborators

• Iran University of Medical Sciences: lead

Study Sites (1)

Rasool Akram Hospital

Tehran, 14455-364, Iran

Location

Related Publications (3)

• 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.

  PMID: 16508426 BACKGROUND

• 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.

  PMID: 12598446 BACKGROUND

• 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.

  PMID: 16815268 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Mehdi Modarres
• Organization: Iran university of medical Sciences

mmodarres51@yahoo.com

009888602217

Study Officials

• Mehdi Modarres, MD

  Iran University of Medical Sciences(IUMS)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 23, 2007
• Study Start: February 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 16, 2018
• Results First Posted: October 16, 2018

Record last verified: 2007-02

Locations

IR (1)