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Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

Primary Purpose

Proliferative Diabetic Retinopathy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bevacizumab
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Proliferative Diabetic Retinopathy, Vitrectomy, Bevacizumab

Eligibility Criteria

9 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Tractional Retinal Detachment involving or threatening the macula,
  • Tractional+Rhegmatogenous Retinal Detachment, or
  • Fibrovascular tissue covering and distorting the macula.

Exclusion Criteria:

  • Vitrectomy
  • Neovascular glaucoma
  • Dense media opacity (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA)

Sites / Locations

  • Department Of Ophthalmology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bevacizumab

Arm Description

Outcomes

Primary Outcome Measures

Intra- and post-operative bleedings were recorded.

Secondary Outcome Measures

Best Corrected Visual Acuity

Full Information

First Posted
December 31, 2009
Last Updated
December 31, 2009
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT01041690
Brief Title
Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease
Official Title
Bevacizumab (Avastin) as an Adjunct to Vitrectomy in the Management of Severe Proliferative Diabetic Retinopathy: a Prospective Case Series
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cairo University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Reports of the use of intravitreal bevacizumab (Avastin, Genentech) for the reduction of neovascularization in proliferative diabetic retinopathy have demonstrated significant regression in the number of new vessels. Reducing the vascularity of neovascular fibrovascular tissue can potentially reduce bleeding intraoperatively and thus facilitate the vitrectomy procedure. The investigators chose to investigate the potential benefit of the use of preoperative bevacizumab in the management of these most complex cases.
Detailed Description
PURPOSE: To evaluate the role of preoperative intravitreal bevacizumab as an adjunct to vitrectomy in the management of severe diabetic eye disease. SETTINGS: Kasr El-Aini Teaching Hospital - Cairo University from 2007 to 2008. METHODS: Twenty eyes of 19 patients with severe proliferative diabetic retinopathy were recruited into the study. All eyes underwent a single intravitreal injection of bevacizumab 1.25 mg in 0.05 ml one week prior to vitrectomy for tractional (14), combined tractional/rhegmatogenous retinal detachment (4), and fibrovascular tissue covering/distorting the macula (2). Exclusion criteria were: previous vitrectomy, neovascular glaucoma, and dense media opacity (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA) that was done pre- and 1 week post injections. Best corrected visual acuity (BCVA), anterior segment with dilated fundus examinations, and intraocular pressures (IOP), were done pre-, 1 week post-injections, 1 day, 1 week and monthly for 3 months post-vitrectomy. Intra- and post-operative bleedings were recorded.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bevacizumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Other Intervention Name(s)
Avastin
Primary Outcome Measure Information:
Title
Intra- and post-operative bleedings were recorded.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Tractional Retinal Detachment involving or threatening the macula, Tractional+Rhegmatogenous Retinal Detachment, or Fibrovascular tissue covering and distorting the macula. Exclusion Criteria: Vitrectomy Neovascular glaucoma Dense media opacity (dense cataract and vitreous hemorrhage) precluding fluorescein angiography (FA)
Facility Information:
Facility Name
Department Of Ophthalmology
City
Cairo
ZIP/Postal Code
11221
Country
Egypt

12. IPD Sharing Statement

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Efficacy of PreOperative Bevacizumab for Diabetic Eye Disease

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