Clinical trial
Traumatic Optic Neuropathy Treatment Trial 2; Efficacy of Different Doses of Erythropoietin. A Multicenter, Double Blind RCT
Name
IUMS 96-03-124-31806
Description
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.
Trial arms
Trial start
2018-01-06
Estimated PCD
2022-08-06
Trial end
2023-03-02
Status
Completed
Phase
Early phase I
Treatment
Recombinant human erythropoietin
Intravenous administration of recombinant human erythropoietin (4000 u/vial) with different dosage for each group
Arms:
Group 1, Group 2, Group 3
Other names:
EPO, Eprex
Size
93
Primary endpoint
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
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '3 treatment groups of patients with TON will receive different total dose of EPO.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Participants are unaware of the dose of EPO. Outcome assessors are masked to the dose of EPO', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 93, 'type': 'ACTUAL'}}
Updated at
2024-03-08
1 organization
1 product
1 indication
Organization
Iran University of Medical SciencesIndication
Traumatic Optic Neuropathy