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NITRO Trial: Neo-adjuvant IntraviTreal Ranibizumab treatment in high risk Ocular melanoma patients: A two stage single centre Phase II single arm study.

NITRO

NITRO Trial: Neo-adjuvant IntraviTreal Ranibizumab treatment in high risk Ocular melanoma patients: A two stage single centre Phase II single arm study.
Funding CR:UK
Portfolio Cancer
Interventions Medicine
Randomised No
Status Closed
Start Date 16-Jul-2012

Uveal melanomas have an estimated incidence of 6 per million per year. The average age at presentation is 59 years and there is no gender preponderance. Approximately 40% of all patients die of metastatic disease, which usually involves the liver. This devastating prognosis has remained unchanged over the last 30 years. For many years the standard treatment was removal of the eye, but this radical treatment has been superseded by a variety of methods aimed at conserving the eye and useful vision. In about 30% of patients, eye-conserving treatments are not considered appropriate, because of large tumour size, optic nerve involvement, extensive involvement of ciliary body or iris, or bulky extraocular spread. Such are treated by eye removal. Loss of the eye diminishes quality of life, causing facial deformity and, in some patients, visual handicap. There is scope for reducing the rate of eye removal. One approach would be to reduce tumour size by administering a first step therapy, so that some form of eye-conservative therapy can be administered with a reasonable chance of success.