Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION
Primary Purpose
Triamcinolone Acetonide, Optic Neuropathy, Ischemic
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Triamcinolone Acetonide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Triamcinolone Acetonide
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Triamcinolone Acetonide
placebo
Arm Description
40mg/1ml
1ml
Outcomes
Primary Outcome Measures
Changes of Best corrected visual acuity(BCVA)
Secondary Outcome Measures
Changes of Visual Field
Full Information
NCT ID
NCT02329288
First Posted
December 29, 2014
Last Updated
March 27, 2015
Sponsor
Second Military Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02329288
Brief Title
Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION
Official Title
Retrobulbar Triamcinolone Acetonide Injection in the Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
January 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Military Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triamcinolone Acetonide, Optic Neuropathy, Ischemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Triamcinolone Acetonide
Arm Type
Active Comparator
Arm Description
40mg/1ml
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
1ml
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Changes of Best corrected visual acuity(BCVA)
Time Frame
baseline and 1month, 3month
Secondary Outcome Measure Information:
Title
Changes of Visual Field
Time Frame
baseline and 1month, 3month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DONGYAN PAN, Dr
Phone
86-21-31161995
Email
campus@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shihong zhao
Organizational Affiliation
department of ophthalmology
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION
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