NCT02329288

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

December 29, 2014

Last Update Submit

March 27, 2015

Conditions

Triamcinolone AcetonideOptic Neuropathy, Ischemic

Outcome Measures

Primary Outcomes (1)

  • Changes of Best corrected visual acuity(BCVA)

    baseline and 1month, 3month

Secondary Outcomes (1)

  • Changes of Visual Field

    baseline and 1month, 3month

Study Arms (2)

Triamcinolone Acetonide

ACTIVE COMPARATOR

40mg/1ml

Drug: Triamcinolone Acetonide

placebo

PLACEBO COMPARATOR

1ml

Drug: placebo

Interventions

Triamcinolone AcetonideDRUG
Triamcinolone Acetonide
placeboDRUG
placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (\<30 days)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Optic Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesEye DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • shihong zhao

    department of ophthalmology

    STUDY DIRECTOR

Central Study Contacts

DONGYAN PAN, Dr

CONTACT

86-21-31161995campus@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

March 30, 2015

Record last verified: 2015-03