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

Recruiting

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

• Registration Number: NCT05797896
• Lead Sponsor: Complement Therapeutics

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

Study Timeline

• Study Start: 2023-02-07
• Study First Submitted: 2023-03-22
• Study First Submitted QC: 2023-03-22
• Study First Posted: 2023-04-04
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (22)

Midwest Eye Institute; 🇺🇸 Carmel, Indiana, United States

Global Research Management; 🇺🇸 Glendale, California, United States

Northern California Retina Vitreous Associates; 🇺🇸 Mountain View, California, United States

Retina Research Institute of Texas; 🇺🇸 Abilene, Texas, United States

Moorfields Eye Hospital; 🇬🇧 London, United Kingdom

San Antonio Eye Center; 🇺🇸 San Antonio, Texas, United States

Gloucestershire Royal Hospital; 🇬🇧 Gloucester, United Kingdom

Liverpool Hospital; 🇬🇧 Liverpool, United Kingdom

Belfast City Hospital; 🇬🇧 Belfast, United Kingdom

Nottingham City Hospital; 🇬🇧 Nottingham, United Kingdom

Newcastle Hospital; 🇬🇧 Newcastle, United Kingdom

Sunderland Eye Infirmary; 🇬🇧 Sunderland, United Kingdom

Western Eye Hospital; 🇬🇧 London, United Kingdom

University Hospital Southampton; 🇬🇧 Southampton, United Kingdom

Frimley Park Hospital; 🇬🇧 Frimley, United Kingdom

Mid Atlantic Retina Specialists; 🇺🇸 Hagerstown, Maryland, United States

Verum Research LLC; 🇺🇸 Eugene, Oregon, United States

Texas Retina Associates; 🇺🇸 Plano, Texas, United States

Bradford Royal Infirmary; 🇬🇧 Bradford, United Kingdom

Sierra Eye Associates; 🇺🇸 Reno, Nevada, United States

Retina Service of Wills Eye Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Manchester Royal Eye Hospital; 🇬🇧 Manchester, United Kingdom