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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2007 by Iran University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Iran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00548197
First received: October 22, 2007
Last updated: NA
Last verified: October 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Intravitreal Bevacizumab Injection
Pars Plana Vitrectomy
Tractional Retinal Detachment
Diabetic Retinopathy
Drug: Bevacizumab
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Injection of Bevacizumab Prior to Vitreoretinal Surgery in Diabetic Tractional Retinal Detachment

Resource links provided by NLM:


Further study details as provided by Iran University of Medical Sciences:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: last follow up ]

Secondary Outcome Measures:
  • Anatomic status of the retina [ Time Frame: Last follow up ]

Estimated Enrollment: 50
Study Start Date: February 2007
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: A
Intravitreal Bevacizumab will be injected in this group before performing pars plana vitrectomy
Drug: Bevacizumab
one intravitreal injection of 2.5 mg Bevacizumab 3-5 days before performing pars plana vitrectomy
Other Name: Brand name of Bevacizumab is Avastin

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548197

Contacts
Contact: Mehdi Modarres, MD 00989121266221 modarreszif@yahoo.com

Locations
Iran, Islamic Republic of
Rasool Akram Hospital Recruiting
Tehran, Iran, Islamic Republic of, 14455-364
Sponsors and Collaborators
Iran University of Medical Sciences
Investigators
Study Director: Mehdi Modarres, MD Iran University of Medical Sciences(IUMS)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00548197     History of Changes
Other Study ID Numbers: 85-A-57
Study First Received: October 22, 2007
Last Updated: October 22, 2007
Health Authority: Iran: Ministry of Health

Keywords provided by Iran University of Medical Sciences:
Intravitreal Bevacizumab injection
Pars plana vitrectomy
tractional retinal detachment
Diabetic retinopathy

Additional relevant MeSH terms:
Retinal Detachment
Diabetic Retinopathy
Retinal Diseases
Dissociative Disorders
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mental Disorders
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014