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

Running, not enrolling

Conditions studied: Dry Age-related Macular Degeneration, Geographic Atrophy, Retinal Disease, Macular Degeneration, Macular Atrophy, Retinal Degeneration, Eye Diseases

In brief

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

Key facts

Study ID

NCT05797896

Run by

Complement Therapeutics

People needed

250

Starts

2023-02-07

Expected to finish

2027-07-31

Last updated by the study team

2025-06-13

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

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
• Diabetic retinopathy in either eye. Note: Presence of systemic diabetes with no retinopathy is not exclusionary
• Any other physical condition which would prevent the participant from undertaking imaging procedures
• Any cell or gene therapy in either eye

Where it is running

• 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

Full record on ClinicalTrials.gov

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