Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2009 by Shahid Beheshti Medical University.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Shahid Beheshti Medical University

ClinicalTrials.gov Identifier:

NCT01330524

First received: March 8, 2011

Last updated: April 5, 2011

Last verified: November 2009

History of Changes

Purpose

In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided in two groups 1) control 2) case. In case group Avastin and Triamcinolone will be injected trough vitreal and placebo will be injected in control group. BCVA and Visual field will be then measured in these two groups.

Condition	Intervention	Phase
Acute Nonarteritic Anterior Ischemic Optic Neuropathy	Drug: Avastin and Triamcinolone Other: placebo	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy

Resource links provided by NLM:

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide Bevacizumab

Genetic and Rare Diseases Information Center resources: Optic Neuropathy, Anterior Ischemic

U.S. FDA Resources

Further study details as provided by Shahid Beheshti Medical University:

Primary Outcome Measures:

Changes of Best corrected visual acuity(BCVA) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
outcome method of measurement: Snellen chart

Secondary Outcome Measures:

Changes of Visual Field [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Automated perimeter


Estimated Enrollment:	16
Study Start Date:	January 2010
Estimated Study Completion Date:	November 2011
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Avastin and Triamcinolone	Drug: Avastin and Triamcinolone 1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal
Placebo Comparator: Placebo	Other: placebo 2mg placebo

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (<30 days)

Exclusion criteria:

Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy)
Neurologic defect
Abnormal ESR, CRP, any history of retina or vitreal surgery
Severe corneal opacity which makes retina examination impossible

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: NCT01330524

Locations


Iran, Islamic Republic of
Labbafinejad medical center	Recruiting
Tehran, Iran, Islamic Republic of
Contact: morteza entezari, Associate Professor 00982122585952 entmort@hotmail.com
Principal Investigator: morteza entezari, associat of profesor

Sponsors and Collaborators

Shahid Beheshti Medical University

More Information

No publications provided


Responsible Party:	morteza entezari, Ophthalmic Research center
ClinicalTrials.gov Identifier:	NCT01330524 History of Changes
Other Study ID Numbers:	8749
Study First Received:	March 8, 2011
Last Updated:	April 5, 2011
Health Authority:	Iran: Ethics Committee

Additional relevant MeSH terms:


Ischemia Optic Nerve Diseases Optic Neuropathy, Ischemic Cardiovascular Diseases Cranial Nerve Diseases Eye Diseases Nervous System Diseases Pathologic Processes Vascular Diseases Bevacizumab Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Triamcinolone hexacetonide Angiogenesis Inhibitors	Angiogenesis Modulating Agents Anti-Inflammatory Agents Antineoplastic Agents Enzyme Inhibitors Glucocorticoids Growth Inhibitors Growth Substances Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015

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