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

June 10, 2025 updated by: Complement Therapeutics

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Belfast City Hospital
      • Bradford, United Kingdom, BD9 6TB
        • Bradford Royal Infirmary
      • Frimley, United Kingdom, GU16 7UJ
        • Frimley Park Hospital
      • Gloucester, United Kingdom, GL1 3NN
        • Gloucestershire Royal Hospital
      • Liverpool, United Kingdom, L7 8XP
        • Liverpool Hospital
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital
      • London, United Kingdom, NW1 5QH
        • Western Eye Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Royal Eye Hospital
      • Newcastle, United Kingdom, NE1 4LP
        • Newcastle Hospital
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham City Hospital
      • Southampton, United Kingdom, SO16 6YD
        • University Hospital Southampton
      • Sunderland, United Kingdom, SR2 9HP
        • Sunderland Eye Infirmary
  • United States
    • California
      • Glendale, California, United States, 91204
        • Global Research Management
      • Mountain View, California, United States, 94040
        • Northern California Retina Vitreous Associates
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Midwest Eye Institute
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Mid Atlantic Retina Specialists
    • Nevada
      • Reno, Nevada, United States, 89506
        • Sierra Eye Associates
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Verum Research LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19610
        • Mid Atlantic Retina
    • Texas
      • Abilene, Texas, United States, 79606
        • Retina Research Institute of Texas
      • Plano, Texas, United States, 75075
        • Texas Retina Associates
      • San Antonio, Texas, United States, 78215
        • San Antonio Eye Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. Clinical diagnosis of bilateral GA due to AMD as confirmed by fundoscopy and imaging at Screening
  2. 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
  3. Willing and able to provide written informed consent
  4. Male or female aged 65 years and over

Exclusion Criteria:

  1. 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
  2. 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.
  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 no retinopathy is not exclusionary
  8. Any other physical condition which would prevent the participant from undertaking imaging procedures
  9. Any cell or gene therapy in either eye

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Month 6, 12,18, 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Up to 24 months
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
Up to 24 months
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
Up to 24 months
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
Up to 24 months
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
Up to 24 months
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
Up to 24 months
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
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Complement Therapeutics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marta Ugarte, Manchester Royal Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IGS01
  • i-GAIN (Other Identifier: Complement Thearapeutics)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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