Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV to Treat Diabetic Tractional Retinal Detachment (IBETRA)

Diabetic Retinopathy Clinical Trial

— IBETRA  

Official title:

Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690768
• Other study ID #: IBETRA
• Status: Completed
• Phase: Phase 2
• First received: May 30, 2008
• Last updated: June 3, 2008
• Start date: March 2008
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.

Exclusion Criteria:

• Massive vitreous hemorrhage preventing from detailed posterior pole examination;

• Previous intra-ocular surgery other than cataract surgery

• Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin

• Prothrombin time, partial thromboplastin time or platelet count without normal limits

• History of previous thromboembolic events

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Detachment
• Retinal Diseases

Intervention

Drug:
• Bevacizumab
Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline

Procedure:
• pars plana vitrectomy
pars plana vitrectomy 3 weeks after baseline

Locations

Country	Name	City	State
Brazil	Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of intraoperative intra-ocular bleeding		three weeks	No