The purpose of the study is to investigate the safety and tolerability of the anti-VEGF (vascular endothelial cell growth factor) treatment, ranibizumab, in combination with proton beam irradiation for the treatment of choroidal melanoma by determining the incidence and severity of ocular adverse events. Systemic adverse events will also be evaluated. A secondary objective is to assess the efficacy of ranibizumab in reducing ocular complications that can occur after irradiation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Ranibizumab dose of 0.5mg or 1.0 mg will be administered intravitreally at the time of surgery for tumor localization and then bimonthly for 22 months (total of 12 injections).
Massachusetts Eye & Ear Infirmary
Boston, Massachusetts, United States
incidence and severity of ocular adverse events and systemic adverse events
Time frame: 12 months and 24 months after initial treatment
incidence of radiation-induced complications, vision loss and eye loss
Time frame: 12 months and 24 months after initial treatment
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