Intravitreal Bevacizumab for Neovascular Glaucoma - Full Text View

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00384631

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

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma

Drug Information available for: Bevacizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Intravitreal Bevacizumab for Neovascular Glaucoma; a Randomized Placebo Controlled Clinical Trial

Further study details as provided by Shaheed 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
2: Sham Comparator	Other: subconjunctival normal saline 0.1cc normal saline injection in the subconjunctival space repeated twice at monthly intervals
1: Experimental	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

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

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Shahin Yazdani, MD

Ophthalmic Research Center, Shaheed Beheshti Medical University

More Information

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

Keywords provided by Shaheed Beheshti Medical University:

Neovascular
Glaucoma
Bevacizumab

Avastin
Intravitreal
IOP

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Bevacizumab

Glaucoma, Neovascular
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009