Intravitreal Bevacizumab for Neovascular Glaucoma
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StatusCompleted
Sponsors
Shahid Beheshti University of Medical Sciences
CLINICAL TRIAL: NCT00384631
BioSeek: nct00384631
Keywords
Abstract
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.
Dates
| Last Verified: | 01/31/2008 |
| First Submitted: | 10/03/2006 |
| Estimated Enrollment Submitted: | 10/03/2006 |
| First Posted: | 10/05/2006 |
| Last Update Submitted: | 02/13/2008 |
| Last Update Posted: | 02/14/2008 |
| Actual Study Start Date: | 03/31/2006 |
| Estimated Study Completion Date: | 02/28/2007 |
Condition or disease
Neovascular
Glaucoma
Intervention/treatment
Other: 2
Drug: 1
Phase
-
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Sham Comparator: 2 | Other: 2 0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals |
| Experimental: 1 | Drug: 1 intravitreal injection of avastin 2.5mg repeated twice at monthly intervals |
Eligibility Criteria
| Ages Eligible for Study | 10 Years To 10 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Change in intraocular pressure [6 months]
2. Change in extent of iris neovascularization [6 months]
Secondary Outcome Measures
1. Best corrected visual acuity [6 months]
