Aflibercept (Eylea) Risk Minimisation Study
Research type
Research Study
Full title
Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study
IRAS ID
179725
Contact name
Richard Gale
Contact email
Sponsor organisation
Bayer PLC
Clinicaltrials.gov Identifier
Project #0303530, Protocol #16526
Duration of Study in the UK
0 years, 9 months, 0 days
Research summary
Eylea (aflibercept) is a drug given as an intravitreal (into the eye) injection. It is used for the treatment of neovascular (wet) age-related macular degeneration (wAMD), macular oedema secondary to central retinal vein occlusion (CRVO), Branch Retinal Vein Occlusion (BRVO) and visual impairment due to diabetic macular oedema (DME).
Patients who have received at least one injection with eylea within the last six months and who are returning for another visit will be invited to participate in the study by their clinical care team. They must be able to understand the native language, give consent, be over 18 and be treated with eylea for any indication. They must not have participated in a clinical trial for any eylea indication in the past 12 months.
In the patient assessment, the patients will complete an interviewer-administered questionnaire (10 - 15 minutes) which will contain multiple choice and true/false questions which are designed to find out about patient knowledge and understanding of the key information contained in the educational materials developed by Bayer Health Care. Patients will be asked their age and level of education among other questions. All participants (patients and physicians) will not receive any of these educational materials as part of the study, apart from what they would receive during normal treatment or practice.
60 - 100 physicians in the UK will complete a 20 - 25 minutes online questionnaire to assess their knowledge and understanding of the key safety information in the eylea educational physician materials. Additionally, the lead physician at the sites who participate in the patient assessment will complete the physician survey.
Sites will provide age range, sex, indication, time since first injection, number of injections in last 12 months for all patients approached about the study who would have been eligible whether they participate or not.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0346
Date of REC Opinion
28 May 2015
REC opinion
Favourable Opinion