GALTOS
Research type
Research Study
Full title
Geographic Atrophy Long-Term Outcomes Study: an ambispective non-interventional study to describe the patient demographics, baseline characteristics, and outcomes of patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in clinical practice.
IRAS ID
315118
Contact name
Tunde Peto
Contact email
Sponsor organisation
Apellis Switzerland GmbH
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
Geographic Atrophy Long-Term Outcomes (GALTOS) is a multi-national, multicenter study conducted in patients with diagnosis of Geographic Atrophy (GA) which will involve collection of historic data and future data (over a period of approximately 1 year). It is an observational study meaning no additional tests will be performed compared to routine practice. Patients will follow routine clinical care. This study is sponsored by Apellis Switzerland GmbH and will be conducted in Australia, Canada, France, Germany, Italy, and UK. Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD), a disease that affects the eye. Currently, there are no approved therapies to effectively prevent, treat, or slow GA progression and the cause of GA and how it affects the bodies’ functions are not yet fully understood. Further research is needed to characterize long-term GA progression and the relationship between patient characteristics, GA clinical features, health care resource utilization (HCRU), and healthcare-related quality of life (HRQoL) as well as the economic implications of the disease for patients and caregivers. The rationale for this study is to collect comprehensive information on the burden of GA from patients monitored in routine clinical practice. The observation period is 11 years, with a minimum of 3 years and a maximum of 10 years of historic data and 12 (+6) months of future follow-up data for all patients. This study will involve the primary use of historic data extracted directly from medical records and, when applicable, from image readings of the eye of consented patients as well as data collected into the study eCRFs via patient and caregiver questionnaires completed during the study.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
22/YH/0192
Date of REC Opinion
30 Aug 2022
REC opinion
Further Information Favourable Opinion