Melanoma Clinical Trial
Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma
Summary
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.
Eligibility Criteria
Inclusion Criteria:
Patients with newly diagnosed choroidal melanoma undergoing proton therapy
Tumors >15 mm in largest diameter and/or >5 mm in height
Tumors ≤ 15 mm in largest diameter and ≤ 5 mm in height located ≤ 3 mm from optic disc and/or macula, with best-corrected visual acuity 20/100 or better in study eye
Exclusion Criteria:
History of prior treatment for choroidal melanoma
Pregnancy or lactation
Presence of diabetic retinopathy
History of retinal vascular occlusion or other retinal vascular disease
Active ocular inflammation or history of uveitis in either eye
History of uncontrolled glaucoma (defined as intraocular pressure >30mmHg despite treatment with anti-glaucoma medication) or filtering surgery in the study eye
Previous intravitreal injections of Avastin® in the study eye or in the non-study eye within 30 days.
Concurrent use of systemic anti-VEGF therapy
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There is 1 Location for this study
Boston Massachusetts, 02114, United States
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