NITRO - Version 1

• Research type

  Research Study

• Full title

  Neoadjuvant IntraviTreal Ranibizumab treatment in high risk Ocular melanoma patients: A two stage single centre Phase II single arm study (NITRO Trial)

• IRAS ID

  65690

• Contact name

  Bertil Damato

• Sponsor organisation

  Royal Liverpool and Broadgreen University Hospitals Trust

• Eudract number

  2011-000961-10

• Research summary

  BackgroundUveal melanomas have an incidence of 6 per million per year, of which the experienced MDT at the 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. Study Aims To assess the safety and efficacy of neoadjuvant (before surgery) intravitreous injections of Ranibizumab in high risk ocular melanoma patients. Summary of proposed study Patients with uveal melanoma that require enucleation (eye removal) will be eligible to enter this 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. Patients will then be followed by at 6 weeks, 3 months and 6 months after completion of treatment. Death data will be collected from the cancer registry for all patients.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0656

• Date of REC Opinion

  7 Dec 2011

• REC opinion

  Further Information Favourable Opinion