patients with retinoblastoma MedDRA version: 9.1 Level: SOC Classification code 10015919 Term: Eye disorders
Conditions
Interventions
Trade Name: ALKERAN
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Melphalan
Concentration unit: mg/l milligram(s)/litre
Concentration type: equal
Concentration number: 50
Sponsors
AZIENDA OSPEDALIERA SENESE
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: -Anterior chamber involvement -Secondary glaucoma -Massive vitreous seeding and subretinal seeds -Retinal detachment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Definition of a microtheterization angiographic technique to repeatedly selective cannulation of the ofthalmic artery in RTB patients. 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 | — |
Countries
Italy
Outcome results
None listed