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Traumatic Optic Neuropathy Treatment Trial (TONTT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Tehran University of Medical Sciences
Sponsor:
Collaborators:
Iran University of Medical Sciences
Mashhad University of Medical Sciences
Shahid Beheshti Medical University
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01783847
First received: February 1, 2013
Last updated: March 4, 2014
Last verified: March 2014

February 1, 2013
March 4, 2014
February 2011
February 2015   (final data collection date for primary outcome measure)
Visual function [ Time Frame: change from baseline until 3 months after treatment ] [ Designated as safety issue: No ]
Visual Acuity, Relative Afferent Pupillary Defect, and Color vision 1,2,3 days, 1 week, 2 weeks and 1,3 months after treatment
Same as current
Complete list of historical versions of study NCT01783847 on ClinicalTrials.gov Archive Site
Visual Field [ Time Frame: Change from baseline 3 months after treatment ] [ Designated as safety issue: No ]
Since visual acuity might be too low to allow testing visual field, it will be performed if the visual acuity is good enough for such a test.
Same as current
Not Provided
Not Provided
 
Traumatic Optic Neuropathy Treatment Trial (TONTT)
Study of Visual Recovery After Erythropoietin (EPO) Injection, in Patients With Traumatic Optic Neuropathy (TON)

The pathophysiology of Traumatic Optic Neuropathy (TON) is thought to be multifactorial, and some researchers have also postulated a primary and secondary mechanism of injury.TON is categorized as direct or indirect.In indirect TON cases, the injury to the axons is thought to be induced by shearing forces that are transmitted to the fibers or to the vascular supply of the nerve. Studies have shown that forces applied to the frontal bone and malar eminences are transferred and concentrated in the area near the optic canal. The tight adherence of the optic nerve's dural sheath to the periosteum within the optic canal is also thought to contribute to this segment of the nerve being extremely susceptible to the deformative stresses of the skull bones. Such injury leads to ischemic injury to the axons of the retinal ganglion cells within the optic canal. At present, no studies validate a particular approach to the management of TON. There are three management lines for these patients that include 1)observation only;2)medical treatment with high or megadoses of methylprednisolone; and 3)surgical intervention. Generally no line precedes the others and additionally, medical or surgical interventions may result in serious side effects or complications. In 2005, the results of the Corticosteroid Randomization after Significant Head Injury (CRASH) trial raised concerns regarding the use of mega dose steroids in traumatic brain injury. This study was the largest randomized study that evaluated steroids in patients with traumatic brain injury and was stopped early due to the significantly increased risk of death in patients that received mega dose steroids at their 6-month follow-up when compared with the placebo group (25.7% vs 22.3%; Relative Risk 1.15 Confidence Interval 1.07 to 1.24; p=0.0001). Although the etiology of the increased risk of death was not determined, the findings of this study should be taken into consideration when managing cases of TON with concurrent traumatic brain injury. Very recently it has been shown the cytokine hormone erythropoietin (EPO) that had been long known and used as a valuable agent to promote hematopoiesis has been protective in experimental models of mechanical trauma, neuroinflammation, cerebral and retinal ischemia, and even in a human stroke trial, and most notably in optic nerve transection. A double blind placebo-controlled multicenter trial on EPO add-on treatment in chronic schizophrenic men was performed. Treatment over 12 weeks with high-dose weekly (40,000 IU intravenously) EPO led to significant improvement of cognitive performance compared to placebo controls. Different studies have been performed on the effect of EPO on neuropathy in different studies. The investigators recently published our results on treating patients with TON with EPO and found it safe and effective. Patients were compared with a historical control group of patients who received no treatment for TON. A better visual recovery was found. The aim of this study is to determine the effectiveness of EPO on TON in a Multi- center clinical trial using a semi-experimental design.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Traumatic Optic Neuropathy
Drug: Recombinant human erythropoietin (EPO)
4000 units per vial
Other Name: EPO (Pooyesh darou Co., Tehran)
Experimental: Recombinant human erythropoietin (EPO)
20,000 unit per day of EPO, Intravenous infusion for three sequential days.
Intervention: Drug: Recombinant human erythropoietin (EPO)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
April 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Having indirect traumatic optic neuropathy, not more than 3 weeks between trauma and treatment, normal fundoscopy

Exclusion Criteria:

  • Having other injuries that effect on visual function, direct optic neuropathy, glaucoma, diabetic retinopathy, uncontrolled hypertension, polycythemia, creatinin more than 3 mg/dl, sensitivity to EPO, hyperkalemia, women who use contraceptive pill, pregnant and breast feeding women, history of stroke and cardiovascular diseases, having malignancy
Both
6 Years to 90 Years
No
Iran, Islamic Republic of
 
NCT01783847
90-01-124-12972
Yes
Tehran University of Medical Sciences
Tehran University of Medical Sciences
  • Iran University of Medical Sciences
  • Mashhad University of Medical Sciences
  • Shahid Beheshti Medical University
Study Director: Mohsen B Kashkouli, MD Tehran University of Medical Sciences
Tehran University of Medical Sciences
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP