Bertil Damato research projects
CRUK/10/032: NITRO trial: Neoadjuvant IntraviTreal Ranibizumab treatment in high risk Ocular melanoma patients: A two stage single centre Phase II single arm study.Funding period: 01 October 2011 to 30 September 2014
Funding scheme: Feasibility Study Project Grants
Funding committee: Clinical Trials Awards and Advisory Committee
Uveal melanomas have an incidence of 6 per million per year, of which our experienced multidisciplinary Liverpool Ocular Oncology Centre treats approximately 250-300 new patients per year. Without treatment, these tumours tend to make the eye blind, painful and unsightly.
Patients are assessed and staged according with clinical, radiological and pathological criteria from tumour tissue. Despite the advance of eye (and thus sight) preserving treatments such as plaque or proton beam radiotherapy, its devastating prognosis has remained unchanged over the last 30 years.
However, when tumour size allows those are preferred in view of the clinical and psychosocial implications of radical surgery.
To assess the safety and efficacy of neoadjuvant intravitreous injections of Ranibizumab in high risk ocular melanoma patients.
Summary of proposed study
Patients with uveal melanoma that require enucleation will enter a two-stage Phase II non-randomised single centre clinical trial. After diagnosis and consent, patients will receive 0.5mg in 0.1ml of intra-vitreal Ranibizumab.
Subject to monthly tumour response assessment and provided that tumour progression is excluded treatment will continue 28 days with a second treatment dose. Treatment will continue to a maximum of 6 months doses unless the patient wishes to stop or there is significant toxicity.