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

Last updated: June 10, 2025
Sponsor: Complement Therapeutics
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Retina

Geographic Atrophy

Eye Disease

Treatment

N/A

Clinical Study ID

NCT05797896
IGS01
i-GAIN
  • Ages > 65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinical diagnosis of bilateral GA due to AMD as confirmed by fundoscopy and imagingat Screening

  2. GA lesion sizes of ≥ 1.25 mm2 to ≤ 17 mm2 (approximately 1-7 disc diameters) in atleast 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

Exclusion Criteria:

  1. History of neovascular (wet) AMD or presence of neovascular (wet) AMD in either eyeconfirmed by fundoscopy at screening and/or any pre-existing retinal imaging

  2. History of intravitreal (IVT) injection in the study eye. Note: Intravitrealtreatment with pegcetacoplan (Syfovre®) and avacincaptad pegol (IzervayTM) ifapproved within the participant's country of origin AND if deemed necessary by thePrincipal Investigator (PI) is allowed in the fellow eye only. IVT injections in thestudy 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 noretinopathy is not exclusionary

  8. Any other physical condition which would prevent the participant from undertakingimaging procedures

  9. Any cell or gene therapy in either eye

Study Design

Total Participants: 250
Study Start date:
February 07, 2023
Estimated Completion Date:
July 31, 2027

Study 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

Connect with a study center

  • Belfast City Hospital

    Belfast, BT9 7AB
    United Kingdom

    Site Not Available

  • Bradford Royal Infirmary

    Bradford, BD9 6TB
    United Kingdom

    Site Not Available

  • Frimley Park Hospital

    Frimley, GU16 7UJ
    United Kingdom

    Site Not Available

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN
    United Kingdom

    Site Not Available

  • Leicester Royal Infirmary

    Leicester, LE1 5WW
    United Kingdom

    Site Not Available

  • Liverpool Hospital

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • Moorfields Eye Hospital

    London, EC1V 2PD
    United Kingdom

    Site Not Available

  • Western Eye Hospital

    London, NW1 5QH
    United Kingdom

    Site Not Available

  • Manchester Royal Eye Hospital

    Manchester, M13 9WL
    United Kingdom

    Site Not Available

  • Newcastle Hospital

    Newcastle, NE1 4LP
    United Kingdom

    Site Not Available

  • Nottingham City Hospital

    Nottingham, NG7 2UH
    United Kingdom

    Site Not Available

  • University Hospital Southampton

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP
    United Kingdom

    Site Not Available

  • Global Research Management

    Glendale, California 91204
    United States

    Site Not Available

  • Northern California Retina Vitreous Associates

    Mountain View, California 94040
    United States

    Site Not Available

  • Midwest Eye Institute

    Carmel, Indiana 46290
    United States

    Site Not Available

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno, Nevada 89506
    United States

    Site Not Available

  • Verum Research LLC

    Eugene, Oregon 97401
    United States

    Site Not Available

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania 19610
    United States

    Site Not Available

  • Retina Service of Wills Eye Hospital

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Retina Research Institute of Texas

    Abilene, Texas 79606
    United States

    Site Not Available

  • Texas Retina Associates

    Plano, Texas 75075
    United States

    Site Not Available

  • San Antonio Eye Center

    San Antonio, Texas 78215
    United States

    Site Not Available

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