Intravitreal Bevacizumab for Neovascular Glaucoma (IVB NVG)

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00384631
First received: October 4, 2006
Last updated: February 14, 2008
Last verified: February 2008
  Purpose

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 Intervention
Neovascular
Glaucoma
Other: subconjunctival normal saline
Drug: Avastin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravitreal Bevacizumab for Neovascular Glaucoma; a Randomized Placebo Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti Medical University:

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

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

Enrollment: 26
Study Start Date: April 2006
Study Completion Date: March 2007
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384631

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

No publications provided

ClinicalTrials.gov Identifier: NCT00384631     History of Changes
Other Study ID Numbers: 8414
Study First Received: October 4, 2006
Last Updated: February 14, 2008
Health Authority: Iran: Ethics Committee

Keywords provided by Shahid Beheshti Medical University:
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
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014