Dry Age-related Macular Degeneration, Eye Diseases, Geographic Atrophy, Macular Atrophy, Macular Degeneration, Retinal Degeneration, Retinal Disease
Conditions
Keywords
Dry Age-related Macular Degeneration, Geographic Atrophy, Retinal Disease, Macular Degeneration, Macular Atrophy, Retinal Degeneration, Eye Diseases, AMD, GA
Brief summary
An observational study to investigate the natural history and evaluate biomarkers of participants with geographic atrophy secondary to age-related macular degeneration
Detailed description
Prospective, observational study to assess the relationships between circulating levels of complement proteins measured using the Complement Precision Medicine (CPM) Platform, genetic profile and lesion progression in subjects with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) up to a 24-month period
Interventions
None listed
Sponsors
Complement Therapeutics
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Genetics | Up to 24 months | To investigate the relationship between variants in genes or loci associated with AMD and the complement profile measured using the CPM platform |
| Complement Proteins Intra-individual Variation | Up to 24 months | To determine the intra-individual variation in complement profile using the Complement Precision Medicine (CPM) Platform, in participants with GA |
| Complement Proteins and Progression of GA | Up to 24 months | To investigate whether there is a relationship between progression of GA and complement profile measured using the Complement Precision Medicine (CPM) platform |
| Geographic Atrophy | Up to 24 months | To investigate whether there is a relationship between progression of GA and complement profile measured using the CPM platform |
| Choroidal Blood Flow and GA Lesion Progression | Up to 24 months | To investigate the relationships between choroidal blood flow and structure and GA lesion progression |
| CRP Levels | Up to 24 months | 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 |
| Choroidal Blood Flow and Genetics | Up to 24 months | To investigate the relationship in genes or loci associated with AMD and choroidal blood flow and structure |
Countries
United Kingdom, United States
Outcome results
None listed