Trial Outcomes & Findings for Traumatic Optic Neuropathy Treatment Trial (TONTT) (NCT NCT01783847)

Results Overview

Best corrected visual acuity will measure at 1,2,3 days, 1 week, 2 weeks and 1 month and at least 3 months after treatment. Improvement is defined based on 1) mean logMAR\[12\], 2) 0.3 change in logMAR (improvement, deterioration, and no change) \[12,16\] , 3) mean improvement percentage which is calculated as: improvement%= (logMar ( of VA after treatment)-logMar ( of initial VA))/(logMar(20/13)˟-logMar ( of initial VA) 4) percentage of patients at different ordinal categorization of the BCVA as no light perception (NLP), light perception (LP)and hand motion (HM), count fingers (CF), and ≥ 20/200.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

117 participants

Primary outcome timeframe

Change from baseline at least 3 months after treatment

Results posted on

2019-05-07

Participant Flow

Participant milestones

Participant milestones
Measure	Recombinant Human Erythropoietin (EPO) 20,000 unit per day of EPO, Intravenous infusion for three sequential days. Recombinant human erythropoietin (EPO): 4000 units per vial	Methylprednisolone 250 mg intravenous injection of Methylprednisolone for 3 days.	Observation No any treatment will be given
Overall Study NOT COMPLETED	16	1	0
Overall Study STARTED	85	16	16
Overall Study COMPLETED	69	15	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Traumatic Optic Neuropathy Treatment Trial (TONTT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recombinant Human Erythropoietin (EPO) n=85 Participants 20,000 unit per day of EPO, Intravenous infusion for three sequential days. Recombinant human erythropoietin (EPO): 4000 units per vial	Methylprednisolone n=16 Participants 1 gram per day intravenous injection of Methylprednisolone for 3 days.	Observation n=16 Participants No any treatment will be given	Total n=117 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	30 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	64 Participants n=5 Participants	10 Participants n=7 Participants	12 Participants n=5 Participants	86 Participants n=4 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Continuous	28.4 years STANDARD_DEVIATION 13.9 • n=5 Participants	23.5 years STANDARD_DEVIATION 9.4 • n=7 Participants	29.0 years STANDARD_DEVIATION 13.7 • n=5 Participants	27.8 years STANDARD_DEVIATION 13.4 • n=4 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	14 Participants n=4 Participants
Sex: Female, Male Male	74 Participants n=5 Participants	16 Participants n=7 Participants	13 Participants n=5 Participants	103 Participants n=4 Participants
Region of Enrollment Iran, Islamic Republic of	85 participants n=5 Participants	16 participants n=7 Participants	16 participants n=5 Participants	117 participants n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline at least 3 months after treatment

Population: Seventeen patients with incomplete follow up and not following the treatment protocol were also excluded during the study. There were 100 patients (100 eyes) who completed the study protocol

Best corrected visual acuity will measure at 1,2,3 days, 1 week, 2 weeks and 1 month and at least 3 months after treatment. Improvement is defined based on 1) mean logMAR\[12\], 2) 0.3 change in logMAR (improvement, deterioration, and no change) \[12,16\] , 3) mean improvement percentage which is calculated as: improvement%= (logMar ( of VA after treatment)-logMar ( of initial VA))/(logMar(20/13)˟-logMar ( of initial VA) 4) percentage of patients at different ordinal categorization of the BCVA as no light perception (NLP), light perception (LP)and hand motion (HM), count fingers (CF), and ≥ 20/200.

Outcome measures

Outcome measures
Measure	Recombinant Human Erythropoietin (EPO) n=69 Participants Intravenous EPO 10,000 IU for 5-13 years of age and 20,000 IU for \>13 years/ day for 3 days Recombinant human erythropoietin (EPO): 4000 units per vial	Methylprednisolone n=15 Participants Just Intravenous Methyl prednisolone 250 mg every 6 hours for 3 days. Methyl prednisolone: 250 mg every 6 hours for 3 days.	Observation n=16 Participants Observation Observation: Just observation
Number of Participants With Change/Improvement Visual Acuity From the Beseline	28 Participants	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Change from baseline at least 3 months after treatment

Population: Seventeen patients dropped out of the study due to incomplete follow-up (16 patients from EPO and one patient from Methylprednisolone group)

A positive RAPD means there are differences between the two eyes in the afferent pathway due to retinal or optic nerve disease. Graded from +1 to +4. The higher one is a better grade

Outcome measures

Outcome measures
Measure	Recombinant Human Erythropoietin (EPO) n=69 Participants Intravenous EPO 10,000 IU for 5-13 years of age and 20,000 IU for \>13 years/ day for 3 days Recombinant human erythropoietin (EPO): 4000 units per vial	Methylprednisolone n=15 Participants Just Intravenous Methyl prednisolone 250 mg every 6 hours for 3 days. Methyl prednisolone: 250 mg every 6 hours for 3 days.	Observation n=16 Participants Observation Observation: Just observation
Number of Participants With Relative Afferent Papillary Defect (RAPD) Grade +4	26 Participants	7 Participants	8 Participants

Adverse Events

Recombinant Human Erythropoietin (EPO)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Methylprednisolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Observation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mohsen Bahmani Kashkouli

Iran university of Medical Sciences

Phone: 00989121777003

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place