Traumatic Optic Neuropathy Treatment Trial 2 (TONTT-2)

Iran University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: Traumatic Optic Neuropathy

Treatments: Drug: Recombinant human erythropoietin

Study type: Interventional

Funder types: Other

Identifiers

NCT03308448

IUMS 96-03-124-31806

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 7+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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93 participants in 3 patient groups

Group 1

Active Comparator group

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)

Treatment:

Drug: Recombinant human erythropoietin

Group 2

Active Comparator group

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)

Treatment:

Drug: Recombinant human erythropoietin

Group 3

Active Comparator group

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)

Treatment:

Drug: Recombinant human erythropoietin