Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

Vitreous Hemorrhage Secondary to PDR Clinical Trial

Official title:

Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage Secondary to Diabetic Retinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01091896
• Other study ID #: IBEViH
• Secondary ID: IBEViH
• Status: Recruiting
• Phase: Phase 2
• First received: March 23, 2010
• Last updated: March 23, 2010
• Start date: January 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2010
• Source: University of Sao Paulo
• Contact: Hospital das Clínicas de Ribeirão Preto - USP
• Is FDA regulated: No
• Health authority: National Committee of Ethics in Research: Brazil
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1
• Est. completion date: March 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Vitreous Hemorrhage
• Vitreous Hemorrhage Secondary to PDR

Intervention

Drug:
• Bevacizumab
1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
• bevacizumab
1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas de Ribeirão Preto - University of São Paulo	Ribeirão Preto	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Tonello M, Costa RA, Almeida FP, Barbosa JC, Scott IU, Jorge R. Panretinal photocoagulation versus PRP plus intravitreal bevacizumab for high-risk proliferative diabetic retinopathy (IBeHi study). Acta Ophthalmol. 2008 Jun;86(4):385-9. Epub 2007 Nov 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent vitreous hemorrhage incidence after vitrectomy		3 months	Yes
Secondary	Visual outcome		3 months	Yes