NEW CONSERVATIVE THERAPIES IN RETINOBLASTOMA

NEW CONSERVATIVE THERAPIES IN RETINOBLASTOMA: INTRAVITREAL AND SUBCONJUNCITIVAL INJECTION OF CHEMOTHERAPY in the intraoculars RTBs - INTV-STC-RT-SI-2012

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002825-31-IT

Enrollment

Registered

2012-10-25

Start date

2012-07-01

Completion date

Unknown

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with RTB MedDRA version: 14.1 Level: HLGT Classification code 10030054 Term: Ocular neoplasms System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: SOC Classification code 10015919 Term: Eye disorders System Organ Class: 10015919 - Eye disorders

Interventions

Pharmaceutical Form: Injection Other descriptive name: melphalan Pharmaceutical Form: Injection Other descriptive name: topotecan Pharmaceutical Form: Injection Other descriptive name: topotecan Ph

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: Complete ophthalmoscopic remission at 6 months after intraarterial and systemic chemotherapy;Secondary Objective: To avoid enucleation No collateral systemic side effects 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

Measure	Time frame
Secondary end point(s): To avoid enucleation No collateral systemic side effects Visual function preservation;Timepoint(s) of evaluation of this end point: 6 months	—

Countries

Italy

Contacts

Public ContactUOC di Oftalmologia AOUS

Azienda Ospedaliera Universitaria Senese

mcarladl@gmail.com3207274038

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026