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Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE December 29, 2014
First Posted Date  ICMJE December 31, 2014
Last Update Posted Date March 30, 2015
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
Changes of Best corrected visual acuity(BCVA) [ Time Frame: baseline and 1month, 3month ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
Changes of Best corrected visual acuity(BCVA) [ Time Frame: 3 month ]
Change History Complete list of historical versions of study NCT02329288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
Changes of Visual Field [ Time Frame: baseline and 1month, 3month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2014)
Changes of Visual Field [ Time Frame: 3 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION
Official Title  ICMJE Retrobulbar Triamcinolone Acetonide Injection in the Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Triamcinolone Acetonide
  • Optic Neuropathy, Ischemic
Intervention  ICMJE
  • Drug: Triamcinolone Acetonide
  • Drug: placebo
Study Arms  ICMJE
  • Active Comparator: Triamcinolone Acetonide
    40mg/1ml
    Intervention: Drug: Triamcinolone Acetonide
  • Placebo Comparator: placebo
    1ml
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 29, 2014)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02329288
Other Study ID Numbers  ICMJE SecondMMU2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party pandongyan, Second Military Medical University
Study Sponsor  ICMJE Second Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: shihong zhao department of ophthalmology
PRS Account Second Military Medical University
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP