ABeVi: Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01151722
• Collaborator: (none)
• Enrollment: 2
• Location: 1
• Arms: 3

Study Details

Study Description

Brief Summary

Postoperative vitreous hemorrhage is a common complication after vitrectomy for proliferative diabetic retinopathy. There have been efforts to lower the incidence of postoperative vitreous hemorrhage such as preoperative bevacizumab injection. Bevacizumab (Avastin) is a potent inhibitor of angiogenesis and has been shown to decrease retinal and iris neovascularization in proliferative diabetic retinopathy. Recently there have been reports showing that preoperative bevacizumab injection could reduce intraoperative bleeding from abnormal vessels and could make surgery easier and more successful. Our hypothesis is that intraoperative bevacizumab injection could reduce postoperative vitreous hemorrhage by inhibiting the vessel formation after surgery.

We started the prospective randomized comparative study to determine the effect of pre and intra-operative bevacizumab injection on postoperative vitreous hemorrhage after diabetic vitrectomy in comparison to vitrectomy without any adjuvant drug.

Condition or Disease	Intervention/Treatment	Phase
Recurrent; Hemorrhage	Procedure: bevacizumab injection; Procedure: bevacizumab injection	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Diabetic Vitreous Hemorrhage
• Study Start Date: Dec 1, 2009
• Anticipated Primary Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: no injection no bevacizumab
Experimental: experimental 2 bevacizumab before vitrectomy	Procedure: bevacizumab injection; bevacizumab injection before vitrectomy
Experimental: experimental 3 bevacizumab after vitrectomy	Procedure: bevacizumab injection; bevacizumab injection after vitrectomy

Outcome Measures

Primary Outcome Measures

1. Vitreous hemorrhage recurrence [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas de Ribeirão Preto - University of São Paulo	Ribeirão Preto	Sao Paulo	Brazil	14049-990

Sponsors and Collaborators

• University of Sao Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01151722
• Other Study ID Numbers: HCRP22
• First Posted: Jun 28, 2010
• Last Update Posted: Jun 28, 2010
• Last Verified: Feb 1, 2010

• Additional relevant MeSH terms: Vitreous Hemorrhage; Hemorrhage; Bevacizumab

Study Results

No Results Posted as of Jun 28, 2010