Clinical trial NCT03308448: Traumatic Optic Neuropathy Treatment Trial 2
Official title: Traumatic Optic Neuropathy Treatment Trial 2; Efficacy of Different Doses of Erythropoietin. A Multicenter, Double Blind RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Traumatic Optic Neuropathy
Keywords: Traumatic optic neuropathy
Erythropoietin
EPO
Eprex
Lead sponsor: Iran University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Mashhad University of Medical Sciences
name: Tehran University of Medical Sciences
First posted: 2017-10-12
Enrollment: 93
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 treatment groups of patients with TON will receive different total dose of EPO.
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 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 outcomes:
measure: 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
timeFrame: 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: 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
timeFrame: 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: 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)
timeFrame: before treatment and on day 1, 2 and 3 after treatment.
Other outcomes:
Locations:
city: Tehrān
country: Iran, Islamic Republic of
facility: Iran University of Medical Sciences
state: Tehran
city: Mashhad
country: Iran, Islamic Republic of
facility: Mashhad University of Medical Sciences
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Iran University of Medical Sciences
name: Mohsen B Kashkouli, MD
role: STUDY_CHAIR
References:
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.
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.
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.