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Traumatic Optic Neuropathy Treatment Trial 2 (TONTT-2)

Primary Purpose

Traumatic Optic Neuropathy

Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Recombinant human erythropoietin
Sponsored by
Iran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Optic Neuropathy focused on measuring Traumatic optic neuropathy, Erythropoietin, EPO, Eprex

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iran University of Medical Sciences
  • Mashhad University of Medical Sciences
  • Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

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.
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

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
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.
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
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.
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)
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.

Full Information

First Posted
September 24, 2017
Last Updated
March 31, 2023
Sponsor
Iran University of Medical Sciences
Collaborators
Mashhad University of Medical Sciences, Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03308448
Brief Title
Traumatic Optic Neuropathy Treatment Trial 2
Acronym
TONTT-2
Official Title
Traumatic Optic Neuropathy Treatment Trial 2; Efficacy of Different Doses of Erythropoietin. A Multicenter, Double Blind RCT
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 6, 2018 (Actual)
Primary Completion Date
August 6, 2022 (Actual)
Study Completion Date
March 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Iran University of Medical Sciences
Collaborators
Mashhad University of Medical Sciences, Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Optic Neuropathy
Keywords
Traumatic optic neuropathy, Erythropoietin, EPO, Eprex

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
3 treatment groups of patients with TON will receive different total dose of EPO.
Masking
ParticipantOutcomes Assessor
Masking Description
Participants are unaware of the dose of EPO. Outcome assessors are masked to the dose of EPO
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Recombinant human erythropoietin
Other Intervention Name(s)
EPO, Eprex
Intervention Description
Intravenous administration of recombinant human erythropoietin (4000 u/vial) with different dosage for each group
Primary Outcome Measure Information:
Title
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.
Description
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)
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
Secondary Outcome Measure Information:
Title
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
Description
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.
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
Title
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
Description
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.
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
Title
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)
Description
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.
Time Frame
before treatment and on day 1, 2 and 3 after treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Having indirect traumatic optic neuropathy(with normal eye and fundus exam) Trauma to treatment interval of 3 weeks and less Age of 7 years and more Exclusion Criteria: Direct optic neuropathy, Glaucoma, Any retinopathy Globe laceration Age under 7 Hypertension, Polycythemia, Creatinin more than 3 mg/dl, Sensitivity to EPO Patients who have received any other form of treatment for their traumatic optic neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsen B Kashkouli, MD
Organizational Affiliation
Iran University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Iran University of Medical Sciences
City
Tehrān
State/Province
Tehran
Country
Iran, Islamic Republic of
Facility Name
Mashhad University of Medical Sciences
City
Mashhad
Country
Iran, Islamic Republic of
Facility Name
Tehran University of Medical Sciences
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 September 2020 and will be available for 6 months
IPD Sharing Access Criteria
It will be available for all the researchers
Citations:
PubMed Identifier
20890611
Citation
Kashkouli MB, Pakdel F, Sanjari MS, Haghighi A, Nojomi M, Homaee MH, Heirati A. Erythropoietin: a novel treatment for traumatic optic neuropathy-a pilot study. Graefes Arch Clin Exp Ophthalmol. 2011 May;249(5):731-6. doi: 10.1007/s00417-010-1534-3. Epub 2010 Oct 2.
Results Reference
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PubMed Identifier
24986593
Citation
Entezari M, Esmaeili M, Yaseri M. A pilot study of the effect of intravenous erythropoetin on improvement of visual function in patients with recent indirect traumatic optic neuropathy. Graefes Arch Clin Exp Ophthalmol. 2014 Aug;252(8):1309-13. doi: 10.1007/s00417-014-2691-6. Epub 2014 Jul 2.
Results Reference
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PubMed Identifier
28986670
Citation
Kashkouli MB, Yousefi S, Nojomi M, Sanjari MS, Pakdel F, Entezari M, Etezad-Razavi M, Razeghinejad MR, Esmaeli M, Shafiee M, Bagheri M. Traumatic optic neuropathy treatment trial (TONTT): open label, phase 3, multicenter, semi-experimental trial. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):209-218. doi: 10.1007/s00417-017-3816-5. Epub 2017 Oct 6.
Results Reference
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Traumatic Optic Neuropathy Treatment Trial 2

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