An observational study to investigate the natural history and evaluate biomarkers of participants with geographic atrophy secondary to age-related macular degeneration
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Clinical diagnosis of bilateral GA due to AMD as confirmed by fundoscopy and imaging at Screening
2. GA lesion sizes of ≥ 1.25 mm2 to ≤ 17 mm2 (approximately 1-7 disc diameters) in at least one eye as per Central Reading Center
3. Willing and able to provide written informed consent
4. Male or female aged 65 years and over
Exclusion Criteria:
1. 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
2. History of intravitreal (IVT) injection in the study eye. Note: Intravitreal treatment with pegcetacoplan (Syfovre®) and avacincaptad pegol (IzervayTM) if approved within the participant's country of origin AND if deemed necessary by the Principal Investigator (PI) is allowed in the fellow eye only. IVT injections in the study eye are prohibited.
3. History of uveitis or endophthalmitis
4. High myopia (more than 6 diopter) in the study eye
5. Any ocular pathology which would impede clear imaging of the macula, e.g. intra-ocular opacities
6. Macular changes from causes other than AMD
7. Diabetic retinopathy in either eye. Note: Presence of systemic diabetes with no retinopathy is not exclusionary
8. Any other physical condition which would prevent the participant from undertaking imaging procedures
9. Any cell or gene therapy in either eye
Primary outcome measure(s)
Levels of complement proteins — Month 6, 12,18, 24 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)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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