Research study to investiagte if Ranibizumab treatment is safe and effective in patients with Ocular melanoma (eye tumour) before surgery.

Phase 1

• Conditions: veal Melanoma (requiring enucleation); MedDRA version: 14.0 Level: PT Classification code 10025654 Term: Malignant melanoma of sites other than skin System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2011-000961-10-GB
• Lead Sponsor: Royal Liverpool and Broadgreen University Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-08
• Study Completion: 2014-10-29
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 7

Inclusion Criteria

1) Confirmed diagnosis of uveal melanoma requiring enucleation 2) Must have ultrasonographically documented measurable disease within 4 treatment according to the WHO criteria 3) Prior treatments with chemotherapeutic or antiangiogenic agents for other malignancies are allowed after 6 months of discontinuation 4) Age = 18 years 5) Performance Status =2 6) Previous or present vascular intraocular diseases not requiring use of antiangiogenic agents will be allowed 7) Laboratory results: ? Hb = 10g/dl ? Platelets = 100,000mm3 ? WCC = 3.0 x 109/L ? ANC = 1.0 x 109/L ? Bilirubin < twice normal, Alkaline Phosphatase < 5 x normal ? INR ‹ 2 ? Cr = 1.5 ULN 8) Normal blood pressure or controlled hypertension. 9) No recent major surgical procedures (laparotomy or thoracotomy) within 4weeks. 10) No thromboembolic event within 6 months 11) No known coagulopathy disorder. 12) Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial. 13) Before patient registration, written informed consent must be given according to ICH/GCP, and national regulations.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 13
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

1) Serious underlying medical condition according to the judgement of the Principal Investigator 2) Pregnant or nursing patients 3) Inability to provide adequate informed consent. 4) Hypersensitivity to the active substance or to any of the excipients. 5) Active or suspected ocular or periocular infections. 6) Active severe intraocular inflammation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the safety and efficacy (effectiveness) of intravitreal Ranibizumab, in the neoadjuvant (before surgery) setting, in high risk ocular melanoma patients.;Secondary Objective: To describe the toxic effects of intravitreal Ranibizumab in high risk ocular melanoma patients. To explore relationships between ultrasonographic response, serum and intravitreous VEGF levels, and the gene expression profile.;Primary end point(s): To determine response rate of intravitreal Ranibizumab, in the neoadjuvant setting, in large primary ocular melanoma patients.;Timepoint(s) of evaluation of this end point: All patients having completed the T28 tumour assessment after first intravitreal Ranibizumab injection.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To describe the toxic effects of intravitreal Ranibizumab in high risk ocular melanoma patients. To explore relationships between ultrasonographic response, serum and intravenous VEGF levels, and gene expression profile.;Timepoint(s) of evaluation of this end point: The last patient completing the final follow-up visit(6 month)