Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study
NCT ID: NCT05797896
Last Updated: 2025-06-13
Study Results
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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ACTIVE_NOT_RECRUITING
250 participants
OBSERVATIONAL
2023-02-07
2027-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
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
65 Years
ALL
No
Sponsors
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Complement Therapeutics
INDUSTRY
Responsible Party
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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
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
Belfast City Hospital
Belfast, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Frimley Park Hospital
Frimley, , United Kingdom
Gloucestershire Royal Hospital
Gloucester, , United Kingdom
Liverpool Hospital
Liverpool, , United Kingdom
Moorfields Eye Hospital
London, , United Kingdom
Western Eye Hospital
London, , United Kingdom
Manchester Royal Eye Hospital
Manchester, , United Kingdom
Newcastle Hospital
Newcastle, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
University Hospital Southampton
Southampton, , United Kingdom
Sunderland Eye Infirmary
Sunderland, , United Kingdom
Countries
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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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