EW CONSERVATIVE THERAPIES IN RETINOBLASTOMA

Conditions: patients with RTB
MedDRA version: 14.1Level: HLGTClassification code 10030054Term: Ocular neoplasmsSystem Organ Class: 10015919 - Eye disorders
MedDRA version: 14.1Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2012-002825-31-IT

Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 12

Inclusion Criteria

Età compresa fra 0 e 5 anni
Terapia intravitreale: seeding vitreale residuo ( diffuso o focale) dopo chemioterapia sistemica e/o intraarteriosa
Terapia sottocongiuntivale:
Recidiva focale di focolai precedentemente in remisssione oftalmoscopica con o senza seeding vitreale focale
Are the trial subjects under 18? yes
Number of subjects for this age range: 12
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Anterior chamber involvement
Secondary glaucoma
Total retinal detachment in exophitic growth pattern

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Complete ophthalmoscopic remission at 6 months after intraarterial and systemic chemotherapy;Secondary Objective: To avoid enucleation<br> No collateral systemic side effects <br> Visual function preservation;Primary end point(s): Complete ophthalmoscopic remission at 6 months after intraarterial and systemic chemotherapy;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To avoid enucleation<br> No collateral systemic side effects <br> Visual function preservation;Timepoint(s) of evaluation of this end point: 6 months