MedDRA version: 19.1 Level: PT Classification code 10008773 Term: Choroid melanoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Eylea 40 mg/ml, solution injectable en seringue préremplie
Product Name: Aflibercept
Pharmaceutical Form: Solution for injection
Sponsors
CHU de Nice
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years - Choroid melanoma more than 7 mm thick and / or over basal diameter of 15mm treated by proton therapy Are the trial subjects under 18? no 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 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Iris melanoma - Melanoma immediately metastatic - Pregnant or breastfeeding women - Known hypersensitivity to aflibercept (anti-VEGF selected)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare neovascular glaucoma rate 5 years after proton therapy, in patients large with choroid melanoma, between a group of patients treated preventively by intravitreal anti-VEGF versus a second group of patients receiving a false injection.;Secondary Objective: - Compare neovascular glaucoma rates at 2 years after proton therapy. - Comparison of the rate of occurrence of radiation-induced complications: retinopathy, maculopathy, and radiation-induced neuropathies, and exudative retinal detachment. - Comparison of enucleation rate - Description and comparison of changes in visual acuity between the two groups of patients - Description and comparison of the development of the local tumor regression after proton therapy according to groups - Comparison of local recurrence at 2 and 5 years. - Description of changes in intraocular secretion of pro-angiogenic cytokines. - Analysis of the metastasis-free survival, overall and specific at 2 and 5 years. - Comparison of the evolution of quality of life - Comparison of the incidence of local and general adverse events;Primary end point(s): Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp);Timepoint(s) of evaluation of this end point: At 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Compare neovascular glaucoma rates at 2 years after proton therapy. - Comparison of the rate of occurrence of radiation-induced complications: retinopathy, maculopathy, and radiation-induced neuropathies, and exudative retinal detachment. - Comparison of enucleation rate - Description and comparison of changes in visual acuity between the two groups of patients - Description and comparison of the development of the local tumor regression after proton therapy according to groups - Comparison of local recurrence at 2 and 5 years. - Description of changes in intraocular secretion of pro-angiogenic cytokines. - Analysis of the metastasis-free survival, overall and specific at 2 and 5 years. - Comparison of the evolution of quality of life - Comparison of the incidence of local and general adverse events ;Timepoint(s) of evaluation of this end point: - At 2 years after proton therapy. - At 5 years - During 5 years - During 5 years - During 5 years - At 2 and 5 years. - At 5 years - At 2 and 5 years. - During 5 years - During 5 years | — |
Countries
France
Contacts
Public ContactDRCI
CHU de Nice
Outcome results
None listed