Burden of Illness in Geographic Atrophy in the UK, Germany and Ireland
Research type
Research Study
Full title
Cross-Sectional Study Of The Burden Of Illness In Geographic Atrophy In The United Kingdom, Germany And Ireland
IRAS ID
207237
Contact name
Praveen Patel
Contact email
Sponsor organisation
Genentech, A Member of the Roche Group
Duration of Study in the UK
0 years, 11 months, 21 days
Research summary
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD), affecting over 5 million people worldwide, and in the UK is estimated to account for 26% of legal blindness. The incidence of GA increases exponentially with age and there is currently no treatment.
The disease impact on the patient, caregiver and society due to GA is not being well understood. The purpose of this observational study is to assess the clinical details and health-related quality of life of patients with GA compared to patients without GA.
This study also aims to describe the healthcare costs associated with GA and collect data from caregivers of patients with GA in order to understand the effect on the caregiver’s life due to caring for a patient with this condition.
Patients with and without GA meeting the study criteria for eligibility will be invited to participate in the study by the treating physician or research nurse. Information on the study will be provided to the patient.
If patients consent to participate, the physician or a member of the research team will collect data regarding their medical history and other relevant data onto an electronic case report form (eCRF). Patients will be invited to complete questionnaires providing information on patient-reported outcomes (PRO) at time of the visit. In addition, if the GA patient has a caregiver, the caregiver will be invited to complete questionnaires providing information on caregiver-reported outcomes following informed consent.
The study is expected to last approximately 12 months from when the first patient provides informed consent (i.e. signs the consent form).
REC name
HSC REC B
REC reference
16/NI/0260
Date of REC Opinion
30 Nov 2016
REC opinion
Further Information Favourable Opinion