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

Complement Therapeutics

Status: Enrolling

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05797896

i-GAIN (Other Identifier)

IGS01

Details and patient eligibility

About

An observational study to investigate the natural history and evaluate biomarkers of participants with geographic atrophy secondary to age-related macular degeneration

Full 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

Enrollment: 250 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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