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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02329288
Other study ID # SecondMMU2014
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT00759174 - A Study to Assess Whether PDE5 Inhibitors Increase the Chance of Triggering the Onset of Acute NAION
Not yet recruiting NCT05749094 - Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
Withdrawn NCT01607671 - Treatment Study for Ischemic Optic Neuropathy With Opthalmic Timolol Maleate 0.5% Phase 1
Completed NCT00404729 - Neural Conduction Along the Visual Pathways After Oral Treatment With Citicoline in Patients With Optic Nerve Diseases Phase 4