erve Growth Factor (NGF) eye drop administration as visual rescue treatment in visual loss-associated optic gliomas.
- Conditions
- GliomaMedDRA version: 15.0Level: PTClassification code 10030953Term: Optic tract gliomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2011-003030-14-IT
- Lead Sponsor
- POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
children with established diagnosis of Optic Gliomas (OG)
Are the trial subjects under 18? yes
Number of subjects for this age range: 22
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
children with OG associated with NF1 in RC treatment or have to finish treatment program till 12 mounths
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: evaluate the efficacy and safety of conjunctivally applied NGF on optic nerve function;Secondary Objective: nd;Primary end point(s): improvment of visual function;Timepoint(s) of evaluation of this end point: 6 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): na;Timepoint(s) of evaluation of this end point: na