Traumatic Optic Neuropathy Treatment Trial 2 (TONTT-2)

March 6, 2024 updated by: Iran University of Medical Sciences

Traumatic Optic Neuropathy Treatment Trial 2; Efficacy of Different Doses of Erythropoietin. A Multicenter, Double Blind RCT

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

93

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Mashhad, Iran, Islamic Republic of
        • Mashhad University Of Medical Sciences
      • Tehran, Iran, Islamic Republic of
        • Tehran University of Medical Sciences
    • Tehran
      • Tehrān, Tehran, Iran, Islamic Republic of
        • Iran University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • EPO, Eprex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
Change in Mean number of visible color plates in Color vision test book. It is from 14/14 to 0/14 as assessed by Ishihara 14-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 14-plate color vision test book, the color vision will be recorded as a fraction of 14 plates; e.g. 10/14. Patients with lower than 20/200 vision will have 0/14 since they can not read the color plates.
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
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.
before treatment and on day 1, 2 and 3 after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iran University of Medical Sciences

Collaborators

Tehran University of Medical Sciences
Mashhad University of Medical Sciences

Investigators

  • Study Chair: Mohsen B Kashkouli, MD, Iran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2018

Primary Completion (Actual)

August 6, 2022

Study Completion (Actual)

March 2, 2023

Study Registration Dates

First Submitted

September 24, 2017

First Submitted That Met QC Criteria

October 8, 2017

First Posted (Actual)

October 12, 2017

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IUMS 96-03-124-31806

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All IPD information will be available at the end of the study after submitting for publication

IPD Sharing Time Frame

It will be published in around February 2024 and will be available for 6 months

IPD Sharing Access Criteria

It will be available for all the researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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