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

Complement Therapeutics22 sites in 2 countries250 target enrollmentFebruary 7, 2023

ConditionsDry Age-related Macular Degeneration Geographic Atrophy Retinal Disease Macular Degeneration Macular Atrophy Retinal Degeneration Eye Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Age-related Macular Degeneration
Sponsor: Complement Therapeutics
Enrollment: 250
Locations: 22
Primary Endpoint: Levels of complement proteins
Status: Active, not recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

February 7, 2023

End Date

July 31, 2027

Last Updated

10 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Complement Therapeutics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical diagnosis of bilateral GA due to AMD as confirmed by fundoscopy and imaging at Screening
•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
•Willing and able to provide written informed consent
•Male or female aged 65 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
•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.
•History of uveitis or endophthalmitis
•High myopia (more than 6 diopter) in the study eye
•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 in either eye. Note: Presence of systemic diabetes with no retinopathy is not exclusionary
•Any other physical condition which would prevent the participant from undertaking imaging procedures
•Any cell or gene therapy in either eye

Outcomes

Primary Outcomes

Levels of complement proteins

Time Frame: 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)