Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo

Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy

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.

Study Overview

• Status: Unknown
• Conditions: Acute Nonarteritic Anterior Ischemic Optic Neuropathy
• Intervention / Treatment: Drug: Avastin and Triamcinolone; Other: placebo

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Labbafinejad Medical Center
    • Contact: morteza entezari, Associate Professor; Phone Number: 00982122585952; Email: entmort@hotmail.com
    • Principal Investigator: morteza entezari, associat of profesor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Other: placebo; 2mg placebo
ACTIVE_COMPARATOR: Avastin and Triamcinolone	Drug: Avastin and Triamcinolone; 1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Best corrected visual acuity(BCVA)	outcome method of measurement: Snellen chart	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of Visual Field	Automated perimeter	6 month

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (ANTICIPATED): November 1, 2010
• Study Completion (ANTICIPATED): November 1, 2011

Study Registration Dates

• First Submitted: March 8, 2011
• First Submitted That Met QC Criteria: April 5, 2011
• First Posted (ESTIMATE): April 7, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): April 7, 2011
• Last Update Submitted That Met QC Criteria: April 5, 2011
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab; Triamcinolone
• Other Study ID Numbers: 8749