Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study

Study Overview
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Brief Summary
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An observational study to evaluate different biomarkers of subjects with geographic atrophy secondary to age-related macular degeneration

Detailed Description
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Prospective, observational study to assess the relationships between circulating levels of complement proteins measured using the Complement Precision Medicine (CPM) Platform, variants in genes and lesion progression in subjects with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) over a 12-month period

Official Title
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A Multicentre, Natural History, Non-interventional Study Evaluating Biomarkers In Participants With Geographic Atrophy(GA) Secondary To Age-Related Macular Degeneration (AMD)

Conditions
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Dry Age-related Macular Degeneration, Geographic Atrophy, Retinal Disease, Macular Degeneration, Macular Atrophy, Retinal Degeneration, Eye Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of GA due to AMD (present in one or both eyes) as confirmed by fundoscopy and/or any pre-existing retinal imaging at Screening Willing and able to provide written informed consent Male or female aged 18 years and over Exclusion Criteria: History of neovascular (wet) AMD or presence of neovascular (wet) AMD in either eye confirmed by fundoscopy at screening and/or any pre-existing retinal imaging Any ocular pathology which would impede clear imaging of the macula, e.g. intra-ocular opacities Macular changes from causes other than AMD Diabetic retinopathy (presence of diabetes with no retinopathy is not an exclusion criteria) Any physical condition which would prevent the participant from undertaking the imaging procedures

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of complement proteins | To assess the correlation between circulating levels of complement proteins measured using the Complement Precision Medicine (CPM) Platform and Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRP Levels | To observe the influence of any past or concurrent illnesses, in particular inflammation-related illnesses, rise in serum CRP or of any medications on complement profile using the CPM Platform | 12 months | 
| Geographic Atrophy | To investigate whether there is a relationship between rate of GA lesion expansion and complement profile measured using the CPM platform | 12 months | 
| Choroidal Blood Flow | To investigate the relationship in genes or loci associated with AMD and choroidal blood flow and structure | 12 months | 
| Genetics | To investigate the relationship between variants in genes or loci associated with AMD and the complement profile measured using the CPM platform | 12 months |