Status:
UNKNOWN
The Neuroprotective Effect of PEG-GCSF in the Traumatic Optic Neuropathy
Lead Sponsor:
Buddhist Tzu Chi General Hospital
Conditions:
Traumatic Optic Neuropathy
Eligibility:
All Genders
20-70 years
Phase:
EARLY_PHASE1
Brief Summary
The clinical trial will be a phase 1, semi-experimental trial, which will be performed in Hualien Tzu Chi Hospital. Twenty patients will be recruited in this study starting from the 2nd year of the pr...
Eligibility Criteria
Inclusion
- 20-70 years old
- Having indirect traumatic optic neuropathy, one week to 4 weeks after trauma
- Normal disc figure and macula appearance
- Reduced BCVA (Snellen Chart, less than 20/200) or C-24 central visual field loss more than 10 dB (MD\<-10 dB)
- Color vision defect and positive RAPD
- No evidence of direct trauma to ON on spiral orbital and optic canal computer tomography (CT) scan.
- Normal IOP (10-21 mm Hg)
- Normal blood coagulation (prothrombin time: 8\~12s; partial thromboplastin time: 23.9 - 35.5 s; international normalized ratio: 0.85\~1.15)
- Adequate hematologic (absolute neutrophil count ≥1.5 × 109/L, hemoglobin ≥9 g/dL, platelets ≥80 × 109/L, and PT/PTT/INR ≤1.0 × upper limit of normal; ULN)
- Adequate hepatic function (albumin ≥2.8 g/dL, serum bilirubin ≤2.0 mg/dL or ≤2 × ULN, and aspartate aminotransferase and alanine aminotransferase ≤5.0 × ULN)
- Adequate renal function (Serum BUN: 6-22 mg/dl; serum creatinine: 0.7-1.5 mg/dl for men, 0.5-1.2 mg/dl for women)
- No other cranial nerve injuries (cranial nerve examination, nerve number: 1, 3-12)
Exclusion
- Having other injuries that effect on visual function
- Direct optic neuropathy
- No light perception
- Pregnant and breast feeding women
- Having malignancy
- Sickle-cell disease
- G-CSF allergic reaction
- Acute infectious diseases
- Benign Intracranial hypertension symptoms (1. papilledema in both eyes with no spontaneous venous pulsation 2. Increase of peripapillary nerve fiber layer thickness in OCT imaging)
- Associated intracranial hemorrhage or severe skull fracture
- History or evidence of any other clinically condition that, in the opinion of the investigator, would pose a risk to patient's safety or interfere with study procedures, evaluation, or completion:
- Diabetic retinopathy, maculopathy
- Uncontrolled hypertension
- History of stroke and cardiovascular diseases
- Glaucoma
Key Trial Info
Start Date :
July 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06168188
Start Date
July 24 2020
End Date
December 31 2024
Last Update
December 13 2023
Active Locations (1)
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1
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei, Not US Or Canada, Taiwan, 970