i-Gain Study
Research type
Research Study
Full title
A multicentre, natural history, non-interventional study evaluating biomarkers in participants with geographic atrophy(GA) secondary to age-related macular degeneration (AMD)
IRAS ID
318606
Contact name
Marta Ugarte
Contact email
Sponsor organisation
Complement Therapeutics Limited
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This study is being done for research purposes to learn more about Age-related Macular Degeneration (AMD) and in particular, the form known as Geographic Atrophy (GA) or late ‘dry AMD’. We would like to measure the levels of a group of proteins in patients’ blood called complement proteins as they can contribute to the development and progression of AMD. We will use a new technique to do this called the Complement Precision Medicine (CPM) Platform that utilises mass spectrometry. Furthermore, we would also like to study some of the genes that are known to be associated with AMD. Lastly, we would like to take some images of the back of patients’ eyes to document the GA and see if it changes over the course of the study.
This is a multi-centre, natural history non-interventional study to investigate the association between circulating levels of complement proteins measured using the CPM Platform and geographic atrophy in participants with GA. The study will run across approximately 12 UK centres. 250 participants will be analysed at baseline, 6 and 12 months. Screening and Baseline will take place sequentially on the same visit (Visit 1). Written informed consent will be obtained prior to any study procedures. Visit 2 will take place at 6 months after Visit 1 and Visit 3 will take place at 12 months after Visit 1.
Participants who are confirmed by clinical investigation to have GA secondary to AMD will be invited to take part in the study. Participants will be provided with a written information sheet and will have appropriate time (at least 24 hours) to consider the study and have the opportunity to ask questions.
REC name
Wales REC 7
REC reference
22/WA/0309
Date of REC Opinion
14 Nov 2022
REC opinion
Further Information Favourable Opinion