A Phase 3 interventional study of Recombinant human erythropoietin in Traumatic Optic Neuropathy, sponsored by Iran University of Medical Sciences. Completed at 3 sites in Iran, Islamic Republic of. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2024-03-08.
Sponsored by Iran University of Medical Sciences · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
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
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
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
Also known as: EPO, Eprex
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)
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
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.
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
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.
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
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.
Time frame: before treatment and on day 1, 2 and 3 after treatment.
Plan to share: Yes — All IPD information will be available at the end of the study after submitting for publication
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Iran University of Medical Sciences