drugset / Trial / NCT03308448
Traumatic Optic Neuropathy Treatment Trial 2
Phase 3
Completed
93 enrolled
Iran University of Medical Sciences
Mashhad University of Medical Sciences · collabTehran University of Medical Sciences · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2018-01-06
- Primary completion
- 2022-08-06
- Completion
- 2023-03-02
Publications
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | epoetin alfa | Protein / enzyme biologic | 900 iu/kg | Intravenous |
| Comparator | epoetin alfa | Protein / enzyme biologic | 1800 iu/kg | Intravenous |
| Comparator | epoetin alfa | Protein / enzyme biologic | 3600 iu/kg | Intravenous |