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Active, Not Recruiting

NCT Number: NCT05797896

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dry Age-related Macular Degeneration Anetoderma Connective Tissue Diseases Eye Diseases Eye Diseases, Hereditary Geographic Atrophy Macular Atrophy Macular Degeneration Retinal Degeneration Retinal Disease Retinal Diseases Skin Abnormalities Skin Diseases Skin and Connective Tissue Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Belfast City Hospital, Belfast, United Kingdom

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About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. Levels of complement proteins

    Time frame: Month 6, 12,18, 24

    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)

Secondary outcomes

  1. Geographic Atrophy

    Time frame: Up to 24 months

    To investigate whether there is a relationship between progression of GA and complement profile measured using the CPM platform

  2. Genetics

    Time frame: Up to 24 months

    To investigate the relationship between variants in genes or loci associated with AMD and the complement profile measured using the CPM platform

  3. Complement Proteins Intra-individual Variation

    Time frame: Up to 24 months

    To determine the intra-individual variation in complement profile using the Complement Precision Medicine (CPM) Platform, in participants with GA

  4. Complement Proteins and Progression of GA

    Time frame: Up to 24 months

    To investigate whether there is a relationship between progression of GA and complement profile measured using the Complement Precision Medicine (CPM) platform

  5. Choroidal Blood Flow and Genetics

    Time frame: Up to 24 months

    To investigate the relationship in genes or loci associated with AMD and choroidal blood flow and structure

  6. Choroidal Blood Flow and GA Lesion Progression

    Time frame: Up to 24 months

    To investigate the relationships between choroidal blood flow and structure and GA lesion progression

  7. CRP Levels

    Time frame: Up to 24 months

    To observe the influence of any past or concurrent illnesses, in particular inflammation-related illnesses, rise in serum CRP or of any medications on complement profile using the CPM Platform

Sponsors and collaborators

Lead sponsor

Complement Therapeutics

Industry

Registry information

Official study title

A Multicentre, Natural History, Non-interventional Study Evaluating Biomarkers In Participants With Geographic Atrophy(GA) Secondary To Age-Related Macular Degeneration (AMD)

Acronym: i-GAIN

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Apr 4, 2023
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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