Traumatic Optic Neuropathy Treatment Trial 2

Phase 3

Completed

• Conditions: Traumatic Optic Neuropathy
• Interventions: Drug: Recombinant human erythropoietin

• Registration Number: NCT03308448
• Lead Sponsor: Iran University of Medical Sciences

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.

Study Timeline

• Study First Submitted: 2017-09-24
• Study First Submitted QC: 2017-10-08
• Study First Posted: 2017-10-12
• Study Start: 2018-01-06
• Status Verified: 2022-03
• Primary Completion: 2022-08-06
• Study Completion: 2023-03-02
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Recombinant human erythropoietin	Intervention is Intra-Venous injection of Eprex or EPO \[recombinant human erythropoietin, Pooyesh Darou Biopharmaceuticals CO., Tehran, Iran, 4000 unit/ml solution in prefilled syringe\], 300 units/kg/day for three consecutive days (total:900/kg in 3 days)
Group 2	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)
Group 3	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)

Primary Outcome Measures

Name	Time	Method
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.	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	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)

Secondary Outcome Measures

Name	Time	Method
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	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	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.
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)	before treatment and on day 1, 2 and 3 after treatment.	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.
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	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	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.

Trial Locations

Locations (3)

Mashhad University of Medical Sciences; 🇮🇷 Mashhad, Iran, Islamic Republic of

Iran University of Medical Sciences; 🇮🇷 Tehrān, Tehran, Iran, Islamic Republic of

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of