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Intravitreal Bevacizumab for Neovascular Glaucoma (IVB NVG)

Primary Purpose

Neovascular, Glaucoma

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
subconjunctival normal saline
Avastin
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular focused on measuring Neovascular, Glaucoma, Bevacizumab, Avastin, Intravitreal, IOP

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of NVG
  • Vision less than 20/200
  • age 10-80 years

Exclusion Criteria:

  • Uncontrolled Blood Pressure
  • History of thromboembolism
  • Congestive Heart Failure
  • Renal Failure
  • Pregnancy or Lactation
  • Active ocular or periocular infection
  • No light perception

Sites / Locations

  • Labbafinejad Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

2

1

Arm Description

Outcomes

Primary Outcome Measures

Change in intraocular pressure
Change in extent of iris neovascularization

Secondary Outcome Measures

Best corrected visual acuity

Full Information

First Posted
October 4, 2006
Last Updated
February 14, 2008
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00384631
Brief Title
Intravitreal Bevacizumab for Neovascular Glaucoma
Acronym
IVB NVG
Official Title
Intravitreal Bevacizumab for Neovascular Glaucoma; a Randomized Placebo Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Several studies have confirmed high levels of vascular endothelial growth factor (VEGF) in eyes with neovascular glaucoma (NVG). The role of VEGF inhibitors in regression of other neovascular disorders such as wet-type age-related macular degeneration and diabetic macular edema has been described. We aim to evaluate the effect of three intravitreal injections of bevacizumab (Avastin) 2.5 mg versus a sham procedure for treatment of NVG. Outcome measures include intraocular pressure and extent of iris neovascularization. Both study arms will receive conventional treatment for NVG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular, Glaucoma
Keywords
Neovascular, Glaucoma, Bevacizumab, Avastin, Intravitreal, IOP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Sham Comparator
Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
subconjunctival normal saline
Intervention Description
0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals
Intervention Type
Drug
Intervention Name(s)
Avastin
Intervention Description
intravitreal injection of avastin 2.5mg repeated twice at monthly intervals
Primary Outcome Measure Information:
Title
Change in intraocular pressure
Time Frame
6 months
Title
Change in extent of iris neovascularization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Best corrected visual acuity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of NVG Vision less than 20/200 age 10-80 years Exclusion Criteria: Uncontrolled Blood Pressure History of thromboembolism Congestive Heart Failure Renal Failure Pregnancy or Lactation Active ocular or periocular infection No light perception
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahin Yazdani, MD
Organizational Affiliation
Ophthalmic Research Center, Shaheed Beheshti Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Labbafinejad Medical Center
City
Tehran
ZIP/Postal Code
16666
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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Intravitreal Bevacizumab for Neovascular Glaucoma

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