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
• 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
• 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

• Glaucoma
• Glaucoma, Neovascular
• Neovascular

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