search
Back to results

Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Bevacizumab
sham
Sponsored by
University of Campania "Luigi Vanvitelli"
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • vitreous haemorrhage
  • tractional retinal detachment
  • active proliferative diabetic retinopathy.

Exclusion Criteria:

  • neovascular glaucoma
  • cataract
  • combined traction and rhegmatogenous RD

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    7 days

    20 days

    sham

    Arm Description

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    December 3, 2009
    Last Updated
    December 3, 2009
    Sponsor
    University of Campania "Luigi Vanvitelli"
    Collaborators
    Napoli CTO Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01025934
    Brief Title
    Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy
    Official Title
    Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Campania "Luigi Vanvitelli"
    Collaborators
    Napoli CTO Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the role, the safety and the effectiveness of Intravitreal Bevacizumab injections as an adjunct to vitrectomy in the management of severe proliferative diabetic retinopathy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Proliferative Diabetic Retinopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4

    8. Arms, Groups, and Interventions

    Arm Title
    7 days
    Arm Type
    Active Comparator
    Arm Title
    20 days
    Arm Type
    Active Comparator
    Arm Title
    sham
    Arm Type
    Sham Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Bevacizumab
    Intervention Type
    Other
    Intervention Name(s)
    sham

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: vitreous haemorrhage tractional retinal detachment active proliferative diabetic retinopathy. Exclusion Criteria: neovascular glaucoma cataract combined traction and rhegmatogenous RD

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    20135139
    Citation
    di Lauro R, De Ruggiero P, di Lauro R, di Lauro MT, Romano MR. Intravitreal bevacizumab for surgical treatment of severe proliferative diabetic retinopathy. Graefes Arch Clin Exp Ophthalmol. 2010 Jun;248(6):785-91. doi: 10.1007/s00417-010-1303-3. Epub 2010 Feb 5.
    Results Reference
    derived

    Learn more about this trial

    Intravitreal Bevacizumab for Surgical Treatment of Severe Proliferative Diabetic Retinopathy

    We'll reach out to this number within 24 hrs