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

NCT ID: NCT05797896

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-07

Study Completion Date

2027-07-31

Brief Summary

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

Detailed Description

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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

Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Complement Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marta Ugarte

Role: PRINCIPAL_INVESTIGATOR

Manchester Royal Eye Hospital

Locations

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Global Research Management

Glendale, California, United States

Site Status

Northern California Retina Vitreous Associates

Mountain View, California, United States

Site Status

Midwest Eye Institute

Carmel, Indiana, United States

Site Status

Mid Atlantic Retina Specialists

Hagerstown, Maryland, United States

Site Status

Sierra Eye Associates

Reno, Nevada, United States

Site Status

Verum Research LLC

Eugene, Oregon, United States

Site Status

Mid Atlantic Retina

Philadelphia, Pennsylvania, United States

Site Status

Retina Research Institute of Texas

Abilene, Texas, United States

Site Status

Texas Retina Associates

Plano, Texas, United States

Site Status

San Antonio Eye Center

San Antonio, Texas, United States

Site Status

Belfast City Hospital

Belfast, , United Kingdom

Site Status

Bradford Royal Infirmary

Bradford, , United Kingdom

Site Status

Frimley Park Hospital

Frimley, , United Kingdom

Site Status

Gloucestershire Royal Hospital

Gloucester, , United Kingdom

Site Status

Liverpool Hospital

Liverpool, , United Kingdom

Site Status

Moorfields Eye Hospital

London, , United Kingdom

Site Status

Western Eye Hospital

London, , United Kingdom

Site Status

Manchester Royal Eye Hospital

Manchester, , United Kingdom

Site Status

Newcastle Hospital

Newcastle, , United Kingdom

Site Status

Nottingham City Hospital

Nottingham, , United Kingdom

Site Status

University Hospital Southampton

Southampton, , United Kingdom

Site Status

Sunderland Eye Infirmary

Sunderland, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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i-GAIN

Identifier Type: OTHER

Identifier Source: secondary_id

IGS01

Identifier Type: -

Identifier Source: org_study_id

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