Uveal Melanoma (requiring enucleation) MedDRA version: 14.0 Level: PT Classification code 10025654 Term: Malignant melanoma of sites other than skin System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Lucentis
Product Name: Lucentis
Product Code: n/a
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Ranibizum
Sponsors
Royal Liverpool and Broadgreen University Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Confirmed diagnosis of uveal melanoma requiring enucleation 2) Must have ultrasonographically documented measurable disease within 4 treatment according to the WHO criteria 3) Prior treatments with chemotherapeutic or antiangiogenic agents for other malignancies are allowed after 6 months of discontinuation 4) Age = 18 years 5) Performance Status =2 6) Previous or present vascular intraocular diseases not requiring use of antiangiogenic agents will be allowed 7) Laboratory results: ? Hb = 10g/dl ? Platelets = 100,000mm3 ? WCC = 3.0 x 109/L ? ANC = 1.0 x 109/L ? Bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1) Serious underlying medical condition according to the judgement of the Principal Investigator 2) Pregnant or nursing patients 3) Inability to provide adequate informed consent. 4) Hypersensitivity to the active substance or to any of the excipients. 5) Active or suspected ocular or periocular infections. 6) Active severe intraocular inflammation.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To describe the toxic effects of intravitreal Ranibizumab in high risk ocular melanoma patients. To explore relationships between ultrasonographic response, serum and intravenous VEGF levels, and gene expression profile.;Timepoint(s) of evaluation of this end point: The last patient completing the final follow-up visit(6 month) | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and efficacy (effectiveness) of intravitreal Ranibizumab, in the neoadjuvant (before surgery) setting, in high risk ocular melanoma patients.;Secondary Objective: To describe the toxic effects of intravitreal Ranibizumab in high risk ocular melanoma patients. To explore relationships between ultrasonographic response, serum and intravitreous VEGF levels, and the gene expression profile.;Primary end point(s): To determine response rate of intravitreal Ranibizumab, in the neoadjuvant setting, in large primary ocular melanoma patients.;Timepoint(s) of evaluation of this end point: All patients having completed the T28 tumour assessment after first intravitreal Ranibizumab injection. | — |
Countries
United Kingdom
Outcome results
None listed