Retrobulbar Triamcinolone Acetonide Injection in the Treatment of NA-AION

Optic Neuropathy, Ischemic Clinical Trial

Official title:

Retrobulbar Triamcinolone Acetonide Injection in the Treatment of Nonarteritic Anterior Ischemic Optic Neuropathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02329288
• Other study ID #: SecondMMU2014
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 29, 2014
• Last updated: March 27, 2015
• Start date: May 2015
• Est. completion date: January 2016

Study information

• Verified date: March 2015
• Source: Second Military Medical University
• Contact: DONGYAN PAN, Dr
• Phone: 86-21-31161995
• Email: campus[@]126.com
• Is FDA regulated: No
• Health authority: SMMU:china
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Optic Nerve Diseases
• Optic Neuropathy, Ischemic
• Triamcinolone Acetonide

Intervention

Drug:
• Triamcinolone Acetonide

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Second Military Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Best corrected visual acuity(BCVA)		baseline and 1month, 3month	No
Secondary	Changes of Visual Field		baseline and 1month, 3month	No