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Intravitreal Bevacizumab for Neovascular Glaucoma (IVB NVG)

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ClinicalTrials.gov Identifier: NCT00384631
Recruitment Status : Completed
First Posted : October 6, 2006
Last Update Posted : February 15, 2008
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Neovascular Glaucoma Other: subconjunctival normal saline Drug: Avastin

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Neovascular Glaucoma; a Randomized Placebo Controlled Clinical Trial
Study Start Date : April 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Sham Comparator: 2 Other: subconjunctival normal saline
0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals
Experimental: 1 Drug: Avastin
intravitreal injection of avastin 2.5mg repeated twice at monthly intervals


Outcome Measures

Primary Outcome Measures :
  1. Change in intraocular pressure [ Time Frame: 6 months ]
  2. Change in extent of iris neovascularization [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384631


Locations
Iran, Islamic Republic of
Labbafinejad Medical Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Shahin Yazdani, MD Ophthalmic Research Center, Shaheed Beheshti Medical University
More Information

ClinicalTrials.gov Identifier: NCT00384631     History of Changes
Other Study ID Numbers: 8414
First Posted: October 6, 2006    Key Record Dates
Last Update Posted: February 15, 2008
Last Verified: February 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
Neovascular
Glaucoma
Bevacizumab
Avastin
Intravitreal
IOP

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Neovascular
Ocular Hypertension
Eye Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents