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| Name | Class |
|---|---|
| Mashhad University of Medical Sciences | OTHER |
| Tehran University of Medical Sciences | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator | 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) |
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| Group 2 | Active Comparator | 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) |
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| Group 3 | Active Comparator | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human erythropoietin | Drug | Intravenous administration of recombinant human erythropoietin (4000 u/vial) with different dosage for each group |
|
| 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. | 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 |
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohsen B Kashkouli, MD | Iran University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Iran University of Medical Sciences | Tehrān | Tehran Province | Iran | |||
| Mashhad University of Medical Sciences |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20890611 | Background | 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. | |
| 24986593 | Background | 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. |
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All IPD information will be available at the end of the study after submitting for publication
It will be published in around February 2024 and will be available for 6 months
It will be available for all the researchers
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| ID | Term |
|---|---|
| D020221 | Optic Nerve Injuries |
| ID | Term |
|---|---|
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009901 | Optic Nerve Diseases |
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| ID | Term |
|---|---|
| D000068817 | Epoetin Alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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3 treatment groups of patients with TON will receive different total dose of EPO.
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Participants are unaware of the dose of EPO. Outcome assessors are masked to the dose of EPO
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| 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. | 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) | 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. |
| Mashhad |
| Iran |
| Tehran University of Medical Sciences | Tehran | Iran |
| 28986670 | Background | 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. |
| 39461733 | Derived | Abdolalizadeh P, Kashkouli MB, Ghazizadeh M, Pakdel F, Etezad Razavi M, Nojomi M, Abri Aghdam K, Sanjari MS, Karimi N, Ghahvehchian H, Soleimani M, Tabatabaei SA. Traumatic Optic Neuropathy Treatment Trial 2 (TONTT-2): evaluating the efficacy of different doses of erythropoietin - a multicentre, randomised, double-blind clinical trial. Br J Ophthalmol. 2025 Mar 20;109(4):525-532. doi: 10.1136/bjo-2024-325828. |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D005128 | Eye Diseases |
| D014947 | Wounds and Injuries |
| D002241 |
| Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |