Intravitreal Bevacizumab for Neovascular Glaucoma (IVB NVG)

Tracking Information
First Submitted Date ICMJE	October 4, 2006
First Posted Date ICMJE	October 6, 2006
Last Update Posted Date	February 15, 2008
Study Start Date ICMJE	April 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: February 14, 2008)	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; (submitted: February 14, 2008)	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 Applicable
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
Actual Enrollment ICMJE; (submitted: February 14, 2008)	26
Original Enrollment ICMJE	Not Provided
Actual Study 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	No
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