This application was provisionally approved by consensus, subject to the following information being received. Please amend the information sheet and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). Please provide age appropriate information sheets and assent forms for younger participants and amend the existing information sheets and assent/consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). Provide further information on the study design, in particular the unblinding procedures (Ethical Guidelines for Intervention Studies para 5.41) This following information will be reviewed, and a final decision made on the application, by Dr Christine Crooks and Dr Brian Fergus. 3 Ethics ref: 15/NTA/195 Title: Safety and efficacy of ziv Aflibercept compounding in refractory diabetic macular oedema Principal Investigator: Dr Andrew Riley Sponsor: Clock Start Date: 19 November 2015 Dr Andrew (CI) and Ms Sarah Welsh were present in person for discussion of this application. Potential conflicts of interest The asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study The study investigates study drug in refractory diabetic macular oedema (a leading cause of blindness in patients with diabetes). The Researcher(s) explained the treatment options available to patients, emphasising the very high cost of current best available treatment. The cost is unsustainable trial limits its use for care. This protocol uses compounding to reduce the costs from $2k per injection to $113 per injection. This will enable more patients to be treated. Thus, the drug will make treatment more accessible, and potentially increase length of time between required visits. The study involves off label use of a drug (Aflibercept) which has an efficacy profile superior to the current standard treatment in New Zealand. The Researcher(s) confirmed this is a pilot to test an effective drug using a different formulation (compounded). The researchers have used the compounding process for a similar drug in a similar research setting which has become standard practice. Summary of ethical issues (resolved)
This application was provisionally approved by consensus, subject to the following information being received. Please amend the information sheet and consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). Please provide age appropriate information sheets and assent forms for younger participants and amend the existing information sheets and assent/consent form, taking into account the suggestions made by the Committee (Ethical Guidelines for Intervention Studies para 6.22). Provide further information on the study design, in particular the unblinding procedures (Ethical Guidelines for Intervention Studies para 5.41) This following information will be reviewed, and a final decision made on the application, by Dr Christine Crooks and Dr Brian Fergus. 3 Ethics ref: 15/NTA/195 Title: Safety and efficacy of ziv Aflibercept compounding in refractory diabetic macular oedema Principal Investigator: Dr Andrew Riley Sponsor: Clock Start Date: 19 November 2015 Dr Andrew (CI) and Ms Sarah Welsh were present in person for discussion of this application. Potential conflicts of interest The asked members to declare any potential conflicts of interest related to this application. No potential conflicts of interest related to this application were declared by any member. Summary of Study The study investigates study drug in refractory diabetic macular oedema (a leading cause of blindness in patients with diabetes). The Researcher(s) explained the treatment options available to patients, emphasising the very high cost of current best available treatment. The cost is unsustainable limits its use for care. This protocol uses compounding to reduce the costs from $2k per injection to $113 per injection. This will enable more patients to be treated. Thus, the drug will make treatment more accessible, and potentially increase length of time between required visits. The study involves off label use of a drug (Aflibercept) which has an efficacy profile superior to the current standard treatment in New Zealand. The Researcher(s) confirmed this is a pilot to test an effective drug using a different formulation (compounded). The researchers have used the compounding process for a similar drug in a similar research setting which has become standard practice. Summary of ethical issues (resolved) trial
nta-1-dec-15-meeting-minutes.docx