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

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT00690768
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
2
Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pars Plana Vitrectomy (PPV) Versus Preoperative Intravitreal Bevacizumab Plus PPV for Diabetic Tractional Retinal Detachment (IBETRA Study)
Study Start Date :
Mar 1, 2008
Actual Primary Completion Date :
May 1, 2008
Actual Study Completion Date :
May 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Preoperative Intravitreal bevacizumab and pars plana vitrectomy

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

    • Procedure: pars plana vitrectomy
    pars plana vitrectomy 3 weeks after baseline
    Active Comparator: B

    Pars plana vitrectomy only

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

    Outcome Measures

    Primary Outcome Measures

    1. amount of intraoperative intra-ocular bleeding [three weeks]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP Ribeirão Preto São Paulo Brazil 14049-900

    Sponsors and Collaborators

    • University of Sao Paulo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00690768
    Other Study ID Numbers:
    • IBETRA
    First Posted:
    Jun 5, 2008
    Last Update Posted:
    Jun 5, 2008
    Last Verified:
    May 1, 2008
    Keywords provided by , ,
    Diabetic Retinopathy
    Retinal detachment
    Vitreous Hemorrhage
    Bevacizumab
    preoperative
    pars plana vitrectomy
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy
    Retinal Detachment
    Dissociative Disorders
    Bevacizumab

    Study Results

    No Results Posted as of Jun 5, 2008