Study on the Safety and Effectiveness of Nerve Growth Factor CHF6467 for Children and Young Adults with Optic Pathway Glioma

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for a condition known as Optic Pathway Glioma (OPG). This is a type of brain tumor that affects the optic nerves, which are responsible for vision. The treatment being tested is an eye drop formulation containing a substance called Nerve Growth Factor, Recombinant (R100E), also known by its code name CHF6467. The study aims to evaluate the safety and effectiveness of these eye drops in improving the visual function of children and young adults who have this condition.

The purpose of the study is to assess how well the CHF6467 eye drops work in treating visual problems caused by Optic Pathway Glioma, whether or not the condition is associated with a genetic disorder called type 1 neurofibromatosis. Participants in the study will receive multiple doses of the eye drops over a period of time. Some participants will receive the actual medication, while others will receive a placebo, which looks like the medication but does not contain the active ingredient.

The study will follow participants to monitor any changes in their vision and to ensure the treatment is safe. The trial is designed to provide valuable information about the potential benefits of using CHF6467 eye drops for individuals with Optic Pathway Glioma. This research could lead to new treatment options for those affected by this condition, improving their quality of life and visual health.

1 joining the study

Upon joining the study, eligibility is confirmed based on age (3 to 40 years) and diagnosis of optic pathway glioma (OPG) with or without type 1 neurofibromatosis. The condition must be stable, confirmed by two brain MRI scans conducted at least six months prior.

2 initial assessment

An initial assessment is conducted to evaluate visual function. This includes measuring the largest radius of the field of view using a method called kinetic perimetry, which assesses visual angles.

3 medication administration

The medication used in the trial is a painless nerve growth factor, referred to as CHF6467, administered as eye drops. The placebo used in the study has the same composition as the investigational medication, except it does not contain the active ingredient.

4 ongoing treatment

Participants receive multiple doses of the eye drops. The frequency and duration of administration are determined by the study protocol, focusing on assessing the safety and effectiveness of the treatment on visual function.

5 follow-up assessments

Regular follow-up assessments are conducted to monitor visual function and any potential side effects. These assessments help determine the impact of the treatment over time.

6 completion of the study

The study is estimated to conclude by May 18, 2026. Final assessments are conducted to evaluate the overall outcomes of the treatment on visual function.

Who Can Join the Study?

Participants must be between the ages of 3 and 40 years old.
Participants must have a diagnosis of Optic Pathway Glioma (OPG), which is a type of brain tumor that affects the nerves related to vision.
Participants can have type 1 neurofibromatosis (NF-1), a genetic condition that can cause tumors to grow on nerves, but it is not required.
The disease must be stable, meaning it hasn’t changed, as shown by two brain MRI scans done at least 6 months before joining the study.

Who Cannot Join the Study?

Patients who are not diagnosed with Optic Pathway Glioma (OPG) cannot participate. OPG is a type of brain tumor that affects the optic nerve, which is responsible for vision.
Patients who are not within the specified age range for the study cannot participate. The study is for children or young adults.
Patients who are not able to use the study medication, which is a type of eye drop, cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are unable to follow the study procedures or attend the required visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	18.05.2023

Trial locations

PAINLESS Nerve Growth Factor CHF6467: This is an investigational eye drop treatment being studied for its potential to improve visual function in children or young adults who have optic pathway gliomas. These are tumors that affect the nerves responsible for vision. The study aims to determine if these eye drops are safe to use and if they can effectively help in managing the condition.

Investigated diseases:

Optic glioma

Optic Pathway Glioma – Optic pathway glioma is a type of brain tumor that affects the optic nerves, which are responsible for vision. It is most commonly found in children and can be associated with a genetic condition known as neurofibromatosis type 1. The tumor can cause vision problems, including loss of vision, due to its location along the visual pathways. As the tumor grows, it may lead to further visual impairment and other neurological symptoms. The progression of the disease can vary, with some tumors growing slowly and others more rapidly. Regular monitoring is essential to understand how the disease is affecting the individual.

Trial ID:

2024-515753-16-00

Protocol code:

CHF6467-OPG

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effectiveness of Nerve Growth Factor CHF6467 for Children and Young Adults with Optic Pathway Glioma

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