E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | |
E.1.1.1 | Medical condition in easily understood language |
Patient with large choroid melanoma 7 mm thick and / or more than 15 mm of basal diameter treated by proton therapy |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Eye Diseases [C11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008773 |
E.1.2 | Term | Choroid melanoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
- 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age ≥ 18 years - Choroid melanoma more than 7 mm thick and / or over basal diameter of 15mm treated by proton therapy |
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E.4 | Principal exclusion criteria |
- Iris melanoma - Melanoma immediately metastatic - Pregnant or breastfeeding women - Known hypersensitivity to aflibercept (anti-VEGF selected) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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
|
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E.5.2.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
simulation d'injection |
false injection |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |