Ranibizumab in Combination With Proton Beam Irradiation for Choroidal Melanoma

Completed · Phase 1

Conditions studied: Choroidal Melanoma

In brief

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.

Key facts

Study ID

NCT00765921

Run by

Massachusetts Eye and Ear Infirmary

People needed

40

Starts

2008-06-01

Expected to finish

2016-09-01

Last updated by the study team

2016-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts Eye & Ear Infirmary — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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