eovascular glaucoma prevention by intravitreal injections of anti-VEGF in patients treated by protontherapy in case of large choroidal melanoma
Phase 1
- Conditions
- MedDRA version: 19.1Level: PTClassification code 10008773Term: Choroid melanomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2016-003329-40-FR
- Lead Sponsor
- CHU de Nice
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 56
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
- Iris melanoma
- Melanoma immediately metastatic
- Pregnant or breastfeeding women
- Known hypersensitivity to aflibercept (anti-VEGF selected)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method