The Neuroprotective Effect of PEG-GCSF in the Traumatic Optic Neuropathy

Launched by BUDDHIST TZU CHI GENERAL HOSPITAL · Dec 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Neulasta (PEG-GCSF) for patients with Traumatic Optic Neuropathy (TON), a condition that can cause vision problems after an injury to the eye. The trial will take place at Hualien Tzu Chi Hospital and will involve about 20 patients aged 20 to 70 who have experienced indirect traumatic optic neuropathy, meaning their vision has been affected but there is no direct damage to the optic nerve. To join the study, patients must have specific vision issues, such as decreased sharpness of vision and changes in color vision, and must meet other health criteria.

If you or a loved one participates, you will receive an injection of Neulasta in the affected eye after some initial health checks and examinations. This procedure will be done under local anesthesia to minimize discomfort. Participants will stay in the hospital for one day for monitoring and will have follow-up appointments over the next three months to assess their vision and overall health. This study aims to determine if Neulasta can help protect and improve vision in patients with this condition, and participants will be closely observed for any side effects.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 20-70 years old
• • 2. Having indirect traumatic optic neuropathy, one week to 4 weeks after trauma
• • 3. Normal disc figure and macula appearance
• • 4. Reduced BCVA (Snellen Chart, less than 20/200) or C-24 central visual field loss more than 10 dB (MD\<-10 dB)
• • 5. Color vision defect and positive RAPD
• • 6. No evidence of direct trauma to ON on spiral orbital and optic canal computer tomography (CT) scan.
• • 7. Normal IOP (10-21 mm Hg)
• • 8. Normal blood coagulation (prothrombin time: 8\~12s; partial thromboplastin time: 23.9 - 35.5 s; international normalized ratio: 0.85\~1.15)
• • 9. 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)
• • 10. 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)
• • 11. 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)
• • 12. No other cranial nerve injuries (cranial nerve examination, nerve number: 1, 3-12)
• Exclusion Criteria:
• • 1. Having other injuries that effect on visual function
• • 2. Direct optic neuropathy
• • 3. No light perception
• • 4. Pregnant and breast feeding women
• • 5. Having malignancy
• • 6. Sickle-cell disease
• • 7. G-CSF allergic reaction
• • 8. Acute infectious diseases
• • 9. 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)
• • 10. Associated intracranial hemorrhage or severe skull fracture
• 11. 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:
• • 1. Diabetic retinopathy, maculopathy
• • 2. Uncontrolled hypertension
• • 3. History of stroke and cardiovascular diseases
• • 4. Glaucoma