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Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION

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ClinicalTrials.gov Identifier: NCT02329288
Recruitment Status : Unknown
Verified March 2015 by pandongyan, Second Military Medical University.
Recruitment status was:  Not yet recruiting
First Posted : December 31, 2014
Last Update Posted : March 30, 2015
Sponsor:
Information provided by (Responsible Party):
pandongyan, Second Military Medical University

Brief Summary:

NAION produces an ischemic insult in the optic nerve head presumably due to the hypoperfusion of the short ciliary arteries that supply it.

Intravenous injection of glucocorticoid have proven to be effective in treatment of Nonarteritic Anterior Ischemic Optic Neuropathy,but have some side effects. the investigators believe that offering them Retrobulbar Triamcinolone Acetonide Injection that might halt the progression of the visual acuity and visual field loss if our hypothesis is correct, would greatly improve their chances of avoiding blindness.


Condition or disease Intervention/treatment Phase
Triamcinolone Acetonide Optic Neuropathy, Ischemic Drug: Triamcinolone Acetonide Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Retrobulbar Triamcinolone Acetonide Injection in the Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy
Study Start Date : May 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016


Arm Intervention/treatment
Active Comparator: Triamcinolone Acetonide
40mg/1ml
Drug: Triamcinolone Acetonide
Placebo Comparator: placebo
1ml
Drug: placebo



Primary Outcome Measures :
  1. Changes of Best corrected visual acuity(BCVA) [ Time Frame: baseline and 1month, 3month ]

Secondary Outcome Measures :
  1. Changes of Visual Field [ Time Frame: baseline and 1month, 3month ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329288


Contacts
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Contact: DONGYAN PAN, Dr 86-21-31161995 campus@126.com

Sponsors and Collaborators
Second Military Medical University
Investigators
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Study Director: shihong zhao department of ophthalmology

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Responsible Party: pandongyan, M.D., Second Military Medical University
ClinicalTrials.gov Identifier: NCT02329288     History of Changes
Other Study ID Numbers: SecondMMU2014
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: March 30, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Ischemia
Optic Nerve Diseases
Optic Neuritis
Optic Neuropathy, Ischemic
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action