EW CONSERVATIVE THERAPIES IN RETINOBLASTOMA: DIRECT INTRAARTERIAL (OPHTALMIC ARTERY) CHEMOTHERAPY WITH MELPHALAN FOR INTRAOCULAR RETINOBLASTOMA - ART-OFT-RTB-SI-2008

Conditions: patients with retinoblastoma
MedDRA version: 9.1Level: SOCClassification code 10015919Term: Eye disorders

Registration Number: EUCTR2008-005583-14-IT

Lead Sponsor: AZIENDA OSPEDALIERA SENESE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 1th. Diagnosis, Reese-Ellsworth stage Va e Vb - Partial regression after other therapies - Recurrence of the tumor after other therapies
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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
-Massive vitreous seeding and subretinal seeds
-Retinal detachment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Definition of a microtheterization angiographic technique to repeatedly selective cannulation of the ofthalmic artery in RTB patients.<br>Selective intraocular infusion of an active and effective chemotherapeutic agent in advanced RTB.;Secondary Objective: To get a minimal side effect and minimal local toxicity technique;Primary end point(s): To avoid enucleation

Secondary Outcome Measures