Evaluating a new treatment for optic pathway glioma using a painless nerve growth factor
Safety and Efficacy of Multiple Doses of the PAINLESS Nerve Growth Factor CHF6467 in Paediatric Subjects With Optic Pathway Glioma (OPG). A Randomized Clinical Trial (RCT)
This study is testing a new painless treatment to see if it can help protect the vision of people with optic pathway glioma from getting worse.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 3 Years to 40 Years |
| Sex | All |
| Sponsor | Catholic University of the Sacred Heart Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome) |
| Trial ID | NCT05733572 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and efficacy of CHF6467, a recombinant and painless form of nerve growth factor, in patients with optic pathway glioma (OPG) who experience visual damage. The study aims to assess whether CHF6467 can prevent further visual deterioration by targeting neuroprotection rather than tumor reduction. Participants will receive either CHF6467 or a placebo, and their visual function will be monitored over time. The trial includes both pediatric and adult subjects aged 3 to 40 with a confirmed diagnosis of OPG.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric or adult patients aged 3 to 40 with OPG-induced visual damage.
Not a fit: Patients with concurrent ophthalmological disorders that could interfere with the evaluation or those who have received specific antineoplastic treatments within the last 9 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve visual outcomes for patients suffering from optic pathway glioma.
How similar studies have performed: Previous exploratory studies have shown promising results with similar approaches using nerve growth factor in preventing visual damage in OPG patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: - 1. Paediatric or adult subjects between the ages of 3 and 40 (including extremes). 2. Diagnosis of OPG-induced visual damage, with or without type 1 neurofibromatosis (NF-1) 3. Stable disease with two brain MRI checks, performed at least 6 months before screening. Exclusion Criteria: - 1. concomitant ophthalmological disorder that may affect electrophysiological evaluation. 2. radiotherapy or chemotherapy or any other specific antineoplastic treatment within 9 months before entry.
Where this trial is running
Rome
- Catholic University, Policlinico A. Gemelli (Hospital) — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Benedetto Falsini, MD — universita Cattolica del S. Cuore/Fondazione policlinico A. Gemelli, IRCCS
- Study coordinator: Benedetto Falsini, MD
- Email: benedetto.falsini@unicatt.it
- Phone: 0039-06-30156344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.