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NCT Number: NCT03308448

Traumatic Optic Neuropathy Treatment Trial 2

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.

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Key information

Conditions

Traumatic Optic Neuropathy Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Eye Diseases Nervous System Diseases Optic Nerve Diseases Optic Nerve Injuries Trauma, Nervous System Wounds and Injuries

Age range

7 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Iran University of Medical Sciences, Tehrān, Tehran Province, Iran

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having indirect traumatic optic neuropathy(with normal eye and fundus exam)
  • Trauma to treatment interval of 3 weeks and less
  • Age of 7 years and more

Exclusion criteria

  • Direct optic neuropathy,
  • Glaucoma,
  • Any retinopathy
  • Globe laceration
  • Age under 7
  • Hypertension,
  • Polycythemia,
  • Creatinin more than 3 mg/dl,
  • Sensitivity to EPO
  • Patients who have received any other form of treatment for their traumatic optic neuropathy

Treatment and study plan

Recombinant human erythropoietin

Drug

Intravenous administration of recombinant human erythropoietin (4000 u/vial) with different dosage for each group

Other names: EPO, Eprex

Primary outcomes

  1. 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.

    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

    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 outcomes

  1. 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

    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

    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.

  2. 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

    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

    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.

  3. 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)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Iran University of Medical Sciences

Other

Collaborators

  • Mashhad University of Medical Sciences
  • Tehran University of Medical Sciences

Registry information

Official study title

Traumatic Optic Neuropathy Treatment Trial 2; Efficacy of Different Doses of Erythropoietin. A Multicenter, Double Blind RCT

Acronym: TONTT-2

Important dates

Study start
2018
Primary completion
2022
Study completion
2023
First posted
Oct 12, 2017
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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