This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Traumatic Optic Neuropathy Treatment Trial (TONTT) (TONTT)

This study has been completed.
Sponsor:
Collaborators:
Iran University of Medical Sciences
Mashhad University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01783847
First received: February 1, 2013
Last updated: February 3, 2017
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Traumatic Optic Neuropathy Drug: Recombinant human erythropoietin (EPO) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Care Provider
Primary Purpose: Treatment
Official Title: Study of Visual Recovery After Erythropoietin (EPO) Injection, in Patients With Traumatic Optic Neuropathy (TON)

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Visual function [ Time Frame: change from baseline until 3 months after treatment ]
    Visual Acuity, Relative Afferent Pupillary Defect, and Color vision 1,2,3 days, 1 week, 2 weeks and 1,3 months after treatment


Secondary Outcome Measures:
  • Visual Field [ Time Frame: Change from baseline 3 months after treatment ]
    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.


Enrollment: 100
Study Start Date: February 2015
Study Completion Date: February 2017
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Recombinant human erythropoietin (EPO)
20,000 unit per day of EPO, Intravenous infusion for three sequential days.
Drug: Recombinant human erythropoietin (EPO)
4000 units per vial
Other Name: EPO (Pooyesh darou Co., Tehran)
Active Comparator: Methylprednisolone
1 gram per day intravenous injection of Methylprednisolone for 3 days. If vision improved, it will be followed by oral steroid 1 mg/kg/day for 11 days
Drug: Recombinant human erythropoietin (EPO)
4000 units per vial
Other Name: EPO (Pooyesh darou Co., Tehran)
No Intervention: Observation
No any treatment will be given

  Eligibility

Ages Eligible for Study:   6 Years to 90 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01783847

Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Mashad University of Medical Sciences
Mashad, Khorasan, Iran, Islamic Republic of
Iran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 1467744814
Beheshti University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Iran University of Medical Sciences
Mashhad University of Medical Sciences
Shahid Beheshti University of Medical Sciences
Investigators
Study Chair: Mohsen B Kashkouli, MD Iran University of Medical Sciences
  More Information

Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01783847     History of Changes
Other Study ID Numbers: 90-01-124-12972
Study First Received: February 1, 2013
Last Updated: February 3, 2017

Keywords provided by Tehran University of Medical Sciences:
Erythropoietin
Traumatic Optic Neuropathy
Visual function

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Optic Nerve Diseases
Optic Nerve Injuries
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Cranial Nerve Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Methylprednisolone
Epoetin Alfa
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Hematinics

ClinicalTrials.gov processed this record on July 24, 2017