Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01091896
First received: March 23, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

The purpose of this study is to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without bevacizumab injection.


Condition Intervention Phase
Vitreous Hemorrhage Secondary to PDR
Drug: Bevacizumab
Drug: bevacizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Recurrent vitreous hemorrhage incidence after vitrectomy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Visual outcome [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1
Study Start Date: January 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1 - no bevacizumab
Patients will not receive bevacizumab before nor during vitrectomy
Experimental: 2- bevacizumab before vitrectomy
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
Drug: Bevacizumab
1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
Experimental: 3- bevacizumab after vitrectomy
Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
Drug: bevacizumab
1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy

Detailed Description:

Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. We believe that preoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by decreasing the amount of abnormal vessels and intraoperative injection could also reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing first vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy

Exclusion Criteria:

  • follow-up period of less than 3 months
  • not first vitrectomy
  • abnormal blood coagulation
  • uncontrolled hypertension
  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: NCT01091896

Contacts
Contact: Hospital das Clínicas de Ribeirão Preto - USP

Locations
Brazil
Hospital das Clínicas de Ribeirão Preto - University of São Paulo Recruiting
Ribeirão Preto, SP, Brazil, 14049-990
Contact: Felipe Almeida, MD    16 3602-2523 ext 2523    felipeppalmeida@yahoo.com.br   
Principal Investigator: Felipe Almeida, MD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Felipe Almeida, MD University of Sao Paulo
  More Information

Publications:
Responsible Party: Hospital das Clínicas de Ribeirão Preto - University of São Paulo, USP
ClinicalTrials.gov Identifier: NCT01091896     History of Changes
Other Study ID Numbers: IBEViH, IBEViH
Study First Received: March 23, 2010
Last Updated: March 23, 2010
Health Authority: National Committee of Ethics in Research: Brazil

Keywords provided by University of Sao Paulo:
bevacizumab
vitreous hemorrhage
diabetes mellitus

Additional relevant MeSH terms:
Diabetic Retinopathy
Hemorrhage
Vitreous Hemorrhage
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Pathologic Processes
Eye Hemorrhage
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 July 28, 2014