Clinical trial • Phase I/II • Ophthalmology
Nerve growth factor, recombinant (R100E) for Optic pathway glioma
Phase I/II trial of Nerve growth factor, recombinant (R100E) for Optic pathway glioma.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Optic pathway glioma
- Trial Stage
- Phase I/II
- Drug Modality
- Peptide/protein/enzyme
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 10-09-2024
- First CTIS Authorization Date
- 05-11-2024
Trial design
Randomised, the placebo composition is the same of the imp except the active ingredient (placebo arm); no dose or schedule for comparator specified-controlled Phase I/II trial across 1 site in Italy.
- Randomised
- Yes
- Comparator
- The Placebo composition is the same of the IMP except the active ingredient (placebo arm); no dose or schedule for comparator specified
- Target Sample Size
- 36
Eligibility
Recruits 36 paediatric patients.
- Vulnerable Population
- Paediatric participants are included (age range starts at 3). Subject information and informed consent forms are available for adults, parents, children and teenagers (documents: CHF6467 ISF ICF adult; CHF6467 ISF ICF parents; CHF6467 ISF ICF children; CHF6467 ISF ICF teenagers). 'isVulnerablePopulationSelected' is false in the record. Specific consent/assent procedures or languages are not specified in the available data.
Inclusion criteria
- {"criterion_text":"- 1. Paediatric or adult subjects between the ages of 3 and 40 (including extremes).\n- 2.Diagnosis of OPG-induced visual damage, with or without type 1 neurofibromatosis (NF-1)\n- 3.\tStable disease with two brain MRI checks, performed at least 6 months before screening."}
Exclusion criteria
- {"criterion_text":"- 1.\tNo concomitant ophthalmological disorder that may affect electrophysiological evaluation.\n- 2.\tNo radiotherapy or chemotherapy or any other specific antineoplastic treatment within 9 months before entry."}
Endpoints
Primary endpoints
- {"endpoint_text":"- The largest radius of the field of viewmeasured in degrees visual angle by kinetic perimetry according to Goldmann with the aim V/4e","definition_or_measurement_approach":"Measured by kinetic perimetry according to Goldmann with the aim V/4e (largest radius of the field of view measured in degrees visual angle)."}
Recruitment
- Planned Sample Size
- 36
- Recruitment Window Months
- 36
- Consent Approach
- Subject information and informed consent forms are available for adults, parents, children and teenagers (documents listed in the dossier). Parental/guardian consent and age-appropriate child/teenager information/assent documents are provided (files: CHF6467 ISF ICF parents; CHF6467 ISF ICF children; CHF6467 ISF ICF teenagers). No specific languages or additional consent process details are provided in the available data.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 36
Italy
- Latest Decision Or Authorization Date
- 23-03-2026
- Number Of Sites
- 1
- Number Of Participants
- 36
Sites
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC Oculistica
- Principal Investigator Name
- Antonio Ruggiero
- Principal Investigator Email
- Antonio.Ruggiero@unicatt.it
- Contact Person Name
- Antonio Ruggiero
- Contact Person Email
- Antonio.Ruggiero@unicatt.it
- Number Of Participants
- 36
Sponsor
Primary sponsor
- Full Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Italy
Investigational products
- Investigational Product Name
- PAINLESS Nerve Growth Factor CHF6467
- Active Substance
- Nerve growth factor, recombinant (R100E)
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Ocular (eye drops)
- Route
- Ocular (eye drops)
- Authorisation Status
- Investigational
- Investigational Product Name
- The Placebo composition is the same of the IMP except the active ingredient
- Modality
- Other
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