Investigating Geographic Atrophy Insights (i-GAIN) Natural History Study
i-GAIN
A Multicentre, Natural History, Non-interventional Study Evaluating Biomarkers In Participants With Geographic Atrophy(GA) Secondary To Age-Related Macular Degeneration (AMD)
2 other identifiers
observational
250
2 countries
22
Brief Summary
An observational study to investigate the natural history and evaluate biomarkers of participants with geographic atrophy secondary to age-related macular degeneration
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Longer than P75 for all trials
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 7, 2023
CompletedFirst Submitted
Initial submission to the registry
March 22, 2023
CompletedFirst Posted
Study publicly available on registry
April 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
June 13, 2025
June 1, 2025
4.5 years
March 22, 2023
June 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Levels of complement proteins
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)
Month 6, 12,18, 24
Secondary Outcomes (7)
Geographic Atrophy
Up to 24 months
Genetics
Up to 24 months
Complement Proteins Intra-individual Variation
Up to 24 months
Complement Proteins and Progression of GA
Up to 24 months
Choroidal Blood Flow and Genetics
Up to 24 months
- +2 more secondary outcomes
Eligibility Criteria
Approximately 250 participants, age 65 years and older, with bilateral GA due to AMD will be accrued.
You may qualify if:
- 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
You may not qualify if:
- 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
- Any other physical condition which would prevent the participant from undertaking imaging procedures
- Any cell or gene therapy in either eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Global Research Management
Glendale, California, 91204, United States
Northern California Retina Vitreous Associates
Mountain View, California, 94040, United States
Midwest Eye Institute
Carmel, Indiana, 46290, United States
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740, United States
Sierra Eye Associates
Reno, Nevada, 89506, United States
Verum Research LLC
Eugene, Oregon, 97401, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19610, United States
Retina Research Institute of Texas
Abilene, Texas, 79606, United States
Texas Retina Associates
Plano, Texas, 75075, United States
San Antonio Eye Center
San Antonio, Texas, 78215, United States
Belfast City Hospital
Belfast, BT9 7AB, United Kingdom
Bradford Royal Infirmary
Bradford, BD9 6TB, United Kingdom
Frimley Park Hospital
Frimley, GU16 7UJ, United Kingdom
Gloucestershire Royal Hospital
Gloucester, GL1 3NN, United Kingdom
Liverpool Hospital
Liverpool, L7 8XP, United Kingdom
Moorfields Eye Hospital
London, EC1V 2PD, United Kingdom
Western Eye Hospital
London, NW1 5QH, United Kingdom
Manchester Royal Eye Hospital
Manchester, M13 9WL, United Kingdom
Newcastle Hospital
Newcastle, NE1 4LP, United Kingdom
Nottingham City Hospital
Nottingham, NG7 2UH, United Kingdom
University Hospital Southampton
Southampton, SO16 6YD, United Kingdom
Sunderland Eye Infirmary
Sunderland, SR2 9HP, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marta Ugarte
Manchester Royal Eye Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2023
First Posted
April 4, 2023
Study Start
February 7, 2023
Primary Completion (Estimated)
July 31, 2027
Study Completion (Estimated)
July 31, 2027
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share