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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
Second Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triamcinolone Acetonide

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 29, 2014
    Last Updated
    March 27, 2015
    Sponsor
    Second Military Medical University
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    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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