The reference treatment of ocular melanoma is a conservative treatment by proton therapy. Its goal is to treat the tumor while preserving the eyeball and visual acuity. However, ablation of the eyeball is sometimes necessary after proton therapy in the case of neovascular glaucoma. This complication occurs in 7 to 47% of cases (depending on the size of the tumor) and is associated with hypersecretion of Vascular Endothelial Growth Factor (VEGF) related to necrotic and inflammatory tumor tissue after proton therapy or ischemic retina. The intravitreal injections of anti-VEGF are used in the treatment of neovascular radicular glaucoma without avoiding enucleation in all cases. The investigators propose to study the prevention of neovascular glaucoma by intravitreal prophylactic administration of anti-VEGF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Intravitreal injection of aflibercept 40mg/mL will be done on patients. The injections will be performed on the last day of the proton therapy, then 1 and 2 months later for the induction phase. During the maintenance phase, injections will be performed every 3 months for a period of 21 months.
A false injection will be done on patients on the last day of the proton therapy, then 1 and 2 months later for the induction phase. During the maintenance phase, falses injections will be performed every 3 months for a period of 21 months.
CHU de Nice
Nice, France
Occurrence of neovascular glaucoma
Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp)
Time frame: at 5 years
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