Using Neulasta to protect vision in traumatic optic neuropathy

Principle Investigator Initiated Clinical Trial: The Neuroprotective Effect of Novel Long-acting Granulocyte-colony-stimulating Factor (PEG-GCSF) in the Traumatic Optic Neuropathy

This study is testing if Neulasta can help protect vision in people who have recently suffered from traumatic optic neuropathy.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Buddhist Tzu Chi General Hospital (Academic / other)
• Locations: 1 site (Taipei, Not US Or Canada)
• Trial ID: NCT06168188 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the neuroprotective effects of Neulasta® (pegfilgrastim) in patients with traumatic optic neuropathy (TON). It will recruit 20 participants aged 20 to 70 who have experienced indirect traumatic optic neuropathy within the last four weeks. Participants will undergo a series of comprehensive eye and systemic examinations, including visual acuity tests, visual field assessments, and CT scans, to confirm their eligibility. The study will assess the impact of Neulasta on visual function and overall eye health in these patients.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 20-70 who have been diagnosed with indirect traumatic optic neuropathy within one to four weeks post-trauma.

Not a fit: Patients with direct trauma to the optic nerve or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve visual outcomes for patients suffering from traumatic optic neuropathy.

How similar studies have performed: While the specific use of Neulasta for this condition is novel, similar neuroprotective approaches have shown promise in other studies.

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

Where this trial is running

Taipei, Not US Or Canada

• Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation — Taipei, Not US Or Canada, Taiwan (Recruiting)

Study contacts

• Study coordinator: Yao-Tseng Wen, PhD

Conditions Traumatic Optic Neuropathy