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Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

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ClinicalTrials.gov Identifier: NCT01091896
Recruitment Status : Unknown
Verified March 2010 by University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : March 24, 2010
Last Update Posted : March 24, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Vitreous Hemorrhage Secondary to PDR Drug: Bevacizumab Drug: bevacizumab Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy
Study Start Date : January 2010
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Recurrent vitreous hemorrhage incidence after vitrectomy [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Visual outcome [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: March 2010

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Hemorrhage
Vitreous Hemorrhage
Neoplastic Processes
Neoplasms
Pathologic Processes
Eye Hemorrhage
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents