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Dry Age-related Macular Degenerationi-GAINNCT05797896

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

An observational study of Dry Age-related Macular Degeneration and Geographic Atrophy, run by Complement Therapeutics at 22 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 65 years and older
How many people
234 participants
Where
22 sitesin 2 countries
Study dates
7 Feb 2023to 11 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Older adult

Study population: Approximately 250 participants, age 65 years and older, with bilateral GA due to AMD will be accrued.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

22 sites in 2 countries.

22 sites in 2 countries

United Kingdom12 sites

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Bradford Royal Infirmary

    Bradford, BD9 6TB

  • Frimley Park Hospital

    Frimley, GU16 7UJ

  • Gloucestershire Royal Hospital

    Gloucester, GL1 3NN

  • Liverpool Hospital

    Liverpool, L7 8XP

  • Moorfields Eye Hospital

    London, EC1V 2PD

  • Western Eye Hospital

    London, NW1 5QH

  • Manchester Royal Eye Hospital

    Manchester, M13 9WL

  • Newcastle Hospital

    Newcastle, NE1 4LP

  • Nottingham City Hospital

    Nottingham, NG7 2UH

  • University Hospital Southampton

    Southampton, SO16 6YD

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP

Other trials in United Kingdom

United States10 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Midwest Eye Institute

    Carmel, Indiana, 46290

  • Verum Research LLC

    Eugene, Oregon, 97401

  • Global Research Management

    Glendale, California, 91204

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland, 21740

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania, 19610

  • Texas Retina Associates

    Plano, Texas, 75075

  • Sierra Eye Associates

    Reno, Nevada, 89506

  • San Antonio Eye Center

    San Antonio, Texas, 78215

Other trials in United States

About this study

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

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

Read the detailed 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

Keywords
Dry Age-related Macular Degeneration, Geographic Atrophy, Retinal Disease, Macular Degeneration, Macular Atrophy, Retinal Degeneration, Eye Diseases, AMD, GA
Medical subject headings
Geographic Atrophy, Retinal Diseases, Macular Degeneration, Anetoderma, Retinal Degeneration, Eye Diseases

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Month 6, 12,18, 24

Secondary outcomes (7)

  1. Geographic Atrophy

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

    Measured: Up to 24 months

  2. Genetics

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

    Measured: Up to 24 months

  3. Complement Proteins Intra-individual Variation

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

    Measured: Up to 24 months

  4. Complement Proteins and Progression of GA

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

    Measured: Up to 24 months

  5. Choroidal Blood Flow and Genetics

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

    Measured: Up to 24 months

  6. Choroidal Blood Flow and GA Lesion Progression

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

    Measured: Up to 24 months

  7. CRP Levels

    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

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2023
  2. Study start7 Feb 2023
  3. Primary completion11 Dec 2025
  4. Study completion11 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05797896
Sponsor's protocol ID
IGS01
Other IDs
i-GAIN
Acronym
i-GAIN
Status last verified
Oct 2026
First submitted
22 Mar 2023
Last updated
28 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Age-related Macular Degeneration and Geographic Atrophy, run by Complement Therapeutics at 22 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United Kingdom, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Levels of complement proteins (time frame: Month 6, 12,18, 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05797896.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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