Intravitreal Bevacizumab for Neovascular Glaucoma (IVB NVG)

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00384631

First Posted: October 6, 2006

Last Update Posted: February 15, 2008

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Shahid Beheshti University of Medical Sciences

Tracking Information

First Submitted Date ^ICMJE

October 4, 2006

First Posted Date ^ICMJE

October 6, 2006

Last Update Posted Date

February 15, 2008

Start Date ^ICMJE

April 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Change in intraocular pressure [ Time Frame: 6 months ]
Change in extent of iris neovascularization [ Time Frame: 6 months ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00384631 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Best corrected visual acuity [ Time Frame: 6 months ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intravitreal Bevacizumab for Neovascular Glaucoma

Official Title ^ICMJE

Intravitreal Bevacizumab for Neovascular Glaucoma; a Randomized Placebo Controlled Clinical Trial

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Neovascular
Glaucoma

Intervention ^ICMJE

Other: subconjunctival normal saline
0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals
Drug: Avastin
intravitreal injection of avastin 2.5mg repeated twice at monthly intervals

Study Arms

Sham Comparator: 2
Intervention: Other: subconjunctival normal saline
Experimental: 1
Intervention: Drug: Avastin

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

10 Years to 80 Years (Child, Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Iran, Islamic Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00384631

Other Study ID Numbers ^ICMJE

8414

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Shahid Beheshti University of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Shahin Yazdani, MD

Ophthalmic Research Center, Shaheed Beheshti Medical University

PRS Account

Shahid Beheshti University of Medical Sciences

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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