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NCT00384631 Clinical Trial

Intravitreal Bevacizumab for Neovascular Glaucoma

Glaucoma Clinical Trial

— IVB NVG  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00384631
Other study ID # 8414
Secondary ID
Status Completed
Phase N/A
First received October 4, 2006
Last updated February 14, 2008
Start date April 2006
Est. completion date March 2007

Study information
Verified date February 2008
Source hahid Beheshti University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 10 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Iran, Islamic Republic of Labbafinejad Medical Center Tehran

Sponsors (1)
Lead Sponsor Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in intraocular pressure 6 months
Primary Change in extent of iris neovascularization 6 months
Secondary Best corrected visual acuity 6 months
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