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
  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:


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

ClinicalTrials.gov processed this record on September 16, 2014