Traumatic Optic NeuropathyEarly Phase 1NCT06168188
The Neuroprotective Effect of PEG-GCSF in the Traumatic Optic Neuropathy
A Early Phase 1 study testing Neulasta® (pegfilgrastim) in people with Traumatic Optic Neuropathy, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial 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 project to the 3rd year of the project and will go through comprehensive eye and systemic examination in the Hualien Tzu… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Traumatic Optic Neuropathy
- What is being tested?
- Neulasta® (pegfilgrastim)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Jul 2020to 31 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- Having other injuries that effect on visual function
- Direct optic neuropathy
- No light perception
- Pregnant and breast feeding women
- Having malignancy
- Sickle-cell disease
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- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
Taipei, Not US Or Canada, 970
Yao-Tseng Wen, PhD, 886-982208109, ytw193@gmail.com
Yi-Ping Tsai, MD, 886-8-561825 ext. 12719, pitsai123@gmail.com
About this study
Official title: Principle Investigator Initiated Clinical Trial: The Neuroprotective Effect of Novel Long-acting Granulocyte-colony-stimulating Factor (PEG-GCSF) in the Traumatic Optic Neuropathy
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 project to the 3rd year of the project and will go through comprehensive eye and systemic examination in the Hualien Tzu Chi Hospital. Indirect TON (ITON) patients are defined as reduced best corrected visual acuity (BCVA), visual field, color vision, and positive relatively afferent pupillary defect (RAPD) with normal fundus and optic nerve examination and no evidence of direct trauma to optic nerve on spiral orbital and optic canal computer tomography (CT) scan. Therefore, all patients will have examinations of BCVA, visual field, color vision, RAPD, FVEP, CT scan, and IOP for defining ITON patients one day before Neulasta injection. Patient also underwent renal function test, liver function test, coagulation test, and complete blood count before the treatment. Patients who meet the enrollment criteria (inclusion and exclusion) will be fully informed of this treatment and then an informed consent will be obtained. After patient enrolment, the patient will be intravitreally administrated by 0.15 mL of Neulasta in the injured eye. Firstly, the injured eye will be treated with iodine solution for disinfection and then will be treated with Alcaine eye drop for topic anesthesia. The 0.15 mL of Neulasta will be filled into 1 mL of syringe equipped with 30 gauge beveled needle for intravitreal injection. During injection of Neulasta solution, the anterior chamber decompression will be performed for IOP balance. The aqueous humor from anterior chamber will be collected for further microarray analysis. After Neulasta treatment, Tobradex eyedrops (Alcon) will be given on the injected eye, four times a day. Patient will be hospitalized for one day to monitor BCVA, IOP, fundus condition, complete blood count, and any adverse event. During 3-month follow-up trial, each patient will be regularly monitored 7 days and 1, 3 months after treatments by determining the BCVA, the RPAD, the color vision, visual field, the latency of P-100 wave in FVEP, and the RNFL thickness, IOP, and complete blood count.
- Conditions
- Traumatic Optic Neuropathy
- Being tested
- Neulasta® (pegfilgrastim)
- Medical subject headings
- Optic Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neulasta® (pegfilgrastim)Drug
Intravitreal injection of Neulasta® (pegfilgrastim) after TON
| Study group | Role | What they receive |
|---|---|---|
| Neulasta | Experimental | The 0.15 mL of Neulasta will be filled into 1 mL of syringe equipped with 30 gauge beveled needle for intravitreal injection. Receives: Drug: Neulasta® (pegfilgrastim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BCVA
Best corrected visual acuity
Measured: 3 months after treatment
VA
Visual Field
Measured: 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start24 Jul 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Traumatic Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong-Kung Tsai, Buddhist Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168188
- Sponsor's protocol ID
- TCMF-EP 108-01
- Status last verified
- Dec 2023
- First submitted
- 2 Dec 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu PK, Wen YT, Lin W, Kapupara K, Tai M, Tsai RK. Neuroprotective effects of low-dose G-CSF plus meloxicam in a rat model of anterior ischemic optic neuropathy. Sci Rep. 2020 Jun 25;10(1):10351. doi: 10.1038/s41598-020-66977-9.
PubMed 32587280Wen YT, Huang TL, Huang SP, Chang CH, Tsai RK. Early applications of granulocyte colony-stimulating factor (G-CSF) can stabilize the blood-optic-nerve barrier and ameliorate inflammation in a rat model of anterior ischemic optic neuropathy (rAION). Dis Model Mech. 2016 Oct 1;9(10):1193-1202. doi: 10.1242/dmm.025999. Epub 2016 Aug 18.
PubMed 27538969Huang SP, Fang KT, Chang CH, Huang TL, Wen YT, Tsai RK. Autocrine protective mechanisms of human granulocyte colony-stimulating factor (G-CSF) on retinal ganglion cells after optic nerve crush. Exp Eye Res. 2016 Feb;143:132-40. doi: 10.1016/j.exer.2015.10.010. Epub 2015 Oct 28.
PubMed 26518178Tsai RK, Chang CH, Wang HZ. Neuroprotective effects of recombinant human granulocyte colony-stimulating factor (G-CSF) in neurodegeneration after optic nerve crush in rats. Exp Eye Res. 2008 Sep;87(3):242-50. doi: 10.1016/j.exer.2008.06.004. Epub 2008 Jun 17.
PubMed 18602391
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principle Investigator Initiated Clinical Trial: The Neuroprotective Effect of Novel Long-acting Granulocyte-colony-stimulating Factor (PEG-GCSF) in the Traumatic Optic Neuropathy
- ClinicalTrials.gov ID
- NCT06168188
- Acronym / sponsor ID
- TCMF-EP 108-01
- Conditions
- Traumatic Optic Neuropathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 project to the 3rd year of the project and will go through comprehensive eye and systemic examination in the Hualien Tzu Chi Hospital. Indirect TON (ITON) patients are defined as reduced best corrected visual acuity (BCVA), visual field, color vision, and positive relatively afferent pupillary defect (RAPD) with normal fundus and optic nerve examination and no evidence of direct trauma to optic nerve on spiral orbital and optic canal computer tomography (CT) scan. Therefore, all patients will have examinations of BCVA, visual field, color vision, RAPD, FVEP, CT scan, and IOP for defining ITON patients one day before Neulasta injection. Patient also underwent renal function test, liver function test, coagulation test, and complete blood count before the treatment. Patients who meet the enrollment criteria (inclusion and exclusion) will be fully informed of this treatment and then an informed consent will be obtained. After patient enrolment, the patient will be intravitreally administrated by 0.15 mL of Neulasta in the injured eye. Firstly, the injured eye will be treated with iodine solution for disinfection and then will be treated with Alcaine eye drop for topic anesthesia. The 0.15 mL of Neulasta will be filled into 1 mL of syringe equipped with 30 gauge beveled needle for intravitreal injection. During injection of Neulasta solution, the anterior chamber decompression will be performed for IOP balance. The aqueous humor from anterior chamber will be collected for further microarray analysis. After Neulasta treatment, Tobradex eyedrops (Alcon) will be given on the injected eye, four times a day. Patient will be hospitalized for one day to monitor BCVA, IOP, fundus condition, complete blood count, and any adverse event. During 3-month follow-up trial, each patient will be regularly monitored 7 days and 1, 3 months after treatments by determining the BCVA, the RPAD, the color vision, visual field, the latency of P-100 wave in FVEP, and the RNFL thickness, IOP, and complete blood count.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neulasta | Experimental | Drug: Neulasta® (pegfilgrastim)The 0.15 mL of Neulasta will be filled into 1 mL of syringe equipped with 30 gauge beveled needle for intravitreal injection. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- Having other injuries that effect on visual function
- Direct optic neuropathy
- No light perception
- Pregnant and breast feeding women
- Having malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neulasta® (pegfilgrastim)Intravitreal injection of Neulasta® (pegfilgrastim) after TON | Drug | Neulasta |
Primary outcome
BCVA
Time frame: 3 months after treatment
Best corrected visual acuity
VA
Time frame: 3 months after treatment
Visual Field
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Background: PubMed 32587280Liu PK, Wen YT, Lin W, Kapupara K, Tai M, Tsai RK. Neuroprotective effects of low-dose G-CSF plus meloxicam in a rat model of anterior ischemic optic neuropathy. Sci Rep. 2020 Jun 25;10(1):10351. doi: 10.1038/s41598-020-66977-9.
- Background: PubMed 27538969Wen YT, Huang TL, Huang SP, Chang CH, Tsai RK. Early applications of granulocyte colony-stimulating factor (G-CSF) can stabilize the blood-optic-nerve barrier and ameliorate inflammation in a rat model of anterior ischemic optic neuropathy (rAION). Dis Model Mech. 2016 Oct 1;9(10):1193-1202. doi: 10.1242/dmm.025999. Epub 2016 Aug 18.
- Background: PubMed 26518178Huang SP, Fang KT, Chang CH, Huang TL, Wen YT, Tsai RK. Autocrine protective mechanisms of human granulocyte colony-stimulating factor (G-CSF) on retinal ganglion cells after optic nerve crush. Exp Eye Res. 2016 Feb;143:132-40. doi: 10.1016/j.exer.2015.10.010. Epub 2015 Oct 28.
- Background: PubMed 18602391Tsai RK, Chang CH, Wang HZ. Neuroprotective effects of recombinant human granulocyte colony-stimulating factor (G-CSF) in neurodegeneration after optic nerve crush in rats. Exp Eye Res. 2008 Sep;87(3):242-50. doi: 10.1016/j.exer.2008.06.004. Epub 2008 Jun 17.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Neulasta® (pegfilgrastim) in people with Traumatic Optic Neuropathy, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yao-Tseng Wen, PhD (886-982208109, ytw193@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BCVA (time frame: 3 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06168188, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.