Adjuvant Intravitreal Bevacizumab in Pars Plana Vitrectomy for Vitreous Hemorrhage

• Sponsor: University of Sao Paulo (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01091896
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arms: 3
• Duration (Months): 13.9
• Patients Per Site Per Month: 0.1

Study Details

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
• Anticipated 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: Jan 1, 2010
• Anticipated Primary Completion Date: Sep 1, 2010
• Anticipated Study Completion Date: Mar 1, 2011

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 [3 months]

Secondary Outcome Measures

1. Visual outcome [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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	SP	Brazil	14049-990

Sponsors and Collaborators

• University of Sao Paulo

Investigators

• Principal Investigator: Felipe Almeida, MD, University of Sao Paulo

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• ClinicalTrials.gov Identifier: NCT01091896
• Other Study ID Numbers: IBEViH; IBEViH
• First Posted: Mar 24, 2010
• Last Update Posted: Mar 24, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: bevacizumab; vitreous hemorrhage; diabetes mellitus
• Additional relevant MeSH terms: Neoplasm Metastasis; Vitreous Hemorrhage; Hemorrhage; Bevacizumab

Study Results

No Results Posted as of Mar 24, 2010