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Traumatic Optic Neuropathy Treatment Trial 2 (TONTT-2)

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ClinicalTrials.gov Identifier: NCT03308448
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : January 30, 2018
Sponsor:
Collaborators:
Mashhad University of Medical Sciences
Shiraz University of Medical Sciences
Tabriz University of Medical Sciences
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Iran University of Medical Sciences

Brief Summary:
After introducing intravenous erythropoietin (EPO) as an option for treatment of patients with indirect traumatic optic neuropathy in 2011 and publishing non inferiority trial in Oct.2017), TONTT2 is aiming to find out the best dose and timing of EPO administration in this group of patients.

Condition or disease Intervention/treatment Phase
Traumatic Optic Neuropathy Drug: Recombinant human erythropoietin Phase 3

Detailed Description:
Patients with TON will be visited. After being eligible to enter the study and obtaining informed consent, they will be randomly assigned into 3 groups of different total dose of intravenous administration of EPO to which patients and outcome assessors will be masked. They will be assessed at different follow up time periods with the last follow up of at least 3 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 3 treatment groups of patients with TON will receive different total dose of EPO.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants are unaware of the dose of EPO. Outcome assessors are masked to the dose of EPO
Primary Purpose: Treatment
Official Title: Traumatic Optic Neuropathy Treatment Trial 2; Efficacy of Different Doses of Erythropoietin. A Multicenter, Double Blind RCT
Actual Study Start Date : January 6, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group 1
Intervention is Intra-Venous injection of Eprex or EPO [recombinant human erythropoietin, Pooyesh Darou Biopharmaceuticals CO., Tehran, Iran, 4000 unit/ml solution in prefilled syringe], 300 units/kg/day for three consecutive days (total:900/kg in 3 days)
Drug: Recombinant human erythropoietin
Intravenous administration of recombinant human erythropoietin (4000 u/vial) with different dosage for each group
Other Name: EPO, Eprex

Active Comparator: Group 2
Intervention is Intra-Venous injection of Eprex or EPO [recombinant human erythropoietin, Pooyesh Darou Biopharmaceuticals CO., Tehran, Iran, 4000 unit/ml solution in prefilled syringe], 600 units/kg/day for three consecutive days (total:1800/kg in 3 days)
Drug: Recombinant human erythropoietin
Intravenous administration of recombinant human erythropoietin (4000 u/vial) with different dosage for each group
Other Name: EPO, Eprex

Active Comparator: Group 3
Intervention is Intra-Venous injection of Eprex or EPO [recombinant human erythropoietin, Pooyesh Darou Biopharmaceuticals CO., Tehran, Iran, 4000 unit/ml solution in prefilled syringe], 600 units/kg/day for three consecutive days then repetition of the same treatment in month 1 (Total: 3600/kg in 2 set of 3-day treatment, 1 month apart)
Drug: Recombinant human erythropoietin
Intravenous administration of recombinant human erythropoietin (4000 u/vial) with different dosage for each group
Other Name: EPO, Eprex




Primary Outcome Measures :
  1. Change in Mean LogMAR Best corrected visual acuity (BCVA) from 20/20 to no light perception (NLP) as assessed by Snellen visual acuity chart and analyzed based on mean LogMAR change. [ Time Frame: Before treatment and on day 1,2,3, 7, 30, and 90 days after the treatment and through study completion, an average of 24 months ]
    Best corrected Visual acuity is measured (Snellen eye chart) and recorded as 20/20-20/25, 20/30, 20/40, 20, 50, 20/70, 20/100, 20/200 and then counting finger (CF), hand motion (HM), light perception (LP), and no light perception (NLP)


Secondary Outcome Measures :
  1. Change in Mean Log Unit of Relative afferent pupillary defect (RAPD) from 0.3 to 1.8 log unit as assessed by Neutral density filter [ Time Frame: Before treatment and on day 1,2,3, 7, 30, and 90 days after the treatment and through study completion, an average of 24 months ]
    RAPD will be measured based on six log unit of 0.3, 0.6, 0.9, 1.2, 1.5,and 1.8 in which the higher the number the higher the severity score of RAPD.

  2. Change in Mean number of visible color plates in Color vision test book. It is from 24/24 to 0/24 as assessed by Ishihara 24-plate color test book [ Time Frame: Before treatment and on day 1,2,3, 7, 30, and 90 days after the treatment and through study completion, an average of 24 months ]
    Using Ishihara 24-plate color vision test book, the color vision will be recorded as a fraction of 24 plates; e.g. 10/24. Patients with lower than 20/200 vision will have 0/24 since they can not read the color plates.

  3. Number of patients with treatment related adverse effects as assessed by history taking (change in mood, vertigo, faint), examination (blood pressure) and blood tests (CBC, BUN, Cr., K, Na, PT, PTT, INR, Ca., Ph) [ Time Frame: before treatment and on day 1, 2 and 3 after treatment. ]
    history taking (change in mood, vertigo, faint), examination (blood pressure) and blood tests (CBC, BUN, Cr., K, Na, PT, PTT, INR, Ca., Ph) will be performed before treatment and on day 1, 2 and 3 after treatment.



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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Having indirect traumatic optic neuropathy(with normal eye and fundus exam)
  2. Trauma to treatment interval of 3 weeks and less
  3. Age of 7 years and more

Exclusion Criteria:

  1. Direct optic neuropathy,
  2. Glaucoma,
  3. Any retinopathy
  4. Globe laceration
  5. Age under 7
  6. Hypertension,
  7. Polycythemia,
  8. Creatinin more than 3 mg/dl,
  9. Sensitivity to EPO
  10. Patients who have received any other form of treatment for their traumatic optic neuropathy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308448


Contacts
Contact: Mohsen B Kashkouli, MD 0098 912 1777003 mkashkouli2@gmail.com
Contact: Mahya Ghazizadeh, MD 0098 912 4777989 mahyagh1990@gmail.com

Locations
Iran, Islamic Republic of
Iran University of Medical Sciences Recruiting
Tehrān, Tehran, Iran, Islamic Republic of
Contact: Mohsen B Kashkouli, MD    0098 912 1777003    mkashkouli2@gmail.com   
Mashhad University of Medical Sciences Recruiting
Mashhad, Iran, Islamic Republic of
Contact: Mohammad Etezad-Razavi, MD    0098 915 5199624    etezadm@mums.ac.ir   
Shiraz University of Medical Sciences Recruiting
Shiraz, Iran, Islamic Republic of
Contact: Mohammad B Abtahi, MD    0098917 7176970    begherabtahi@yahoo.com   
Tabriz University of Medical Sciences Recruiting
Tabriz, Iran, Islamic Republic of
Contact: Dima Andalib    0098914 3111855    dima1366@yahoo.com   
Tehran University of Medical Sciences Recruiting
Tehran, Iran, Islamic Republic of
Contact: Farzad Pakdel, MD    00989123701876    fapakdel@gmail.com   
Sponsors and Collaborators
Iran University of Medical Sciences
Mashhad University of Medical Sciences
Shiraz University of Medical Sciences
Tabriz University of Medical Sciences
Tehran University of Medical Sciences
Investigators
Study Chair: Mohsen B Kashkouli, MD Iran University of Medical Sciences

Publications:
Responsible Party: Iran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03308448     History of Changes
Other Study ID Numbers: IUMS 96-03-124-31806
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD information will be available at the end of the study after submitting for publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: It will be published in around September 2020 and will be available for 6 months
Access Criteria: It will be available for all the researchers
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Iran University of Medical Sciences:
Traumatic optic neuropathy
Erythropoietin
EPO
Eprex

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
Epoetin Alfa
Hematinics