Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Study Overview
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Brief Summary
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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.

Official Title
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A Phase I Single Center Study of Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Conditions
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Choroidal Melanoma

Intervention / Treatment
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* Drug: ranibizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.0 mg ranibizumab<br>1.0 mg intravitreal injection given bi-monthly for 22 months | Drug: ranibizumab<br>* 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).<br>* Other names: Lucentis;|
| Experimental: 0.5 mg ranibizumab<br>0.5 mg intravitreal injection given bi-monthly for 22 months | Drug: ranibizumab<br>* 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).<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence and severity of ocular adverse events and systemic adverse events |  | 12 months and 24 months after initial treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of radiation-induced complications, vision loss and eye loss |  | 12 months and 24 months after initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, neovascular, macular edema, eye enucleation, antibodies, monoclonal, radiation oncology