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Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study | Clinical Trials | Clareo Health

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

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

NCT05797896•Complement Therapeutics

View on ClinicalTrials.gov

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

Eligibility

Age

65 - No limit years

Sex

ALL

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

Locations (22)

Global Research Management

Glendale, California, United States

Northern California Retina Vitreous Associates

Mountain View, California, United States

Midwest Eye Institute

Carmel, Indiana, United States

Mid Atlantic Retina Specialists

Hagerstown, Maryland, United States

Sierra Eye Associates

Reno, Nevada, United States

Verum Research LLC

Eugene, Oregon, United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Texas Retina Associates

Plano, Texas, United States

San Antonio Eye Center

San Antonio, Texas, United States

Key Dates

Start Date

February 7, 2023

Primary Completion Date

July 31, 2027

Completion Date

July 31, 2027

Last Updated

June 13, 2025

Enrollment

250

ESTIMATED participants

Conditions

Dry Age-related Macular DegenerationGeographic AtrophyRetinal DiseaseMacular DegenerationMacular AtrophyRetinal DegenerationEye Diseases

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

NCT06779773

Geographic AtrophyMacular Degeneration

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RECRUITINGPHASE2

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

NCT06990269

Geographic Atrophy Secondary to Age-related Macular Degeneration

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn How Avacincaptad Pegol (Izervay™) is Used in Clinical Practice in People Who Have Geographic Atrophy

Phase 2 Study of ADX-038 in Participants With Geographic Atrophy

A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Macular Degeneration

Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

A Phase IIb Randomized, Multicenter Trial of Subretinal CPCB-RPE1 in Advanced Dry AMD (Geographic Atrophy)

COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Inherited Retinal Disease