Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

NCT ID: NCT01091896

Last Updated: 2010-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2011-03-31

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.

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

Conditions

Vitreous Hemorrhage Secondary to PDR

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

1 - no bevacizumab

Patients will not receive bevacizumab before nor during vitrectomy

Group Type: NO_INTERVENTION

No interventions assigned to this group

2- bevacizumab before vitrectomy

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: DRUG

1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy

3- bevacizumab after vitrectomy

Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy

Group Type: EXPERIMENTAL

bevacizumab

Intervention Type: DRUG

1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy

Interventions

Bevacizumab

1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy

Intervention Type: DRUG

bevacizumab

1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

USP

Principal Investigators

Felipe Almeida, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Hospital das Clínicas de Ribeirão Preto - University of São Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Hospital das Clínicas de Ribeirão Preto - USP

Role: CONTACT

Facility Contacts

Felipe Almeida, MD

Role: primary

felipeppalmeida@yahoo.com.br

16 3602-2523 ext. 2523

References

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. doi: 10.1111/j.1600-0420.2007.01056.x. Epub 2007 Nov 7.

Reference Type: BACKGROUND

PMID: 17995982 (View on PubMed)

Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.

Reference Type: DERIVED

PMID: 37260074 (View on PubMed)

Other Identifiers

IBEViH

Identifier Type: -

Identifier Source: secondary_id

IBEViH

Identifier Type: -

Identifier Source: org_study_id