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

April 8, 2024 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

Recruiting

Conditions

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

Observational

Enrollment (Estimated)

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 Locations

  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Recruiting
        • Belfast City Hospital
        • Contact:
      • Bradford, United Kingdom, BD9 6TB
      • Frimley, United Kingdom, GU16 7UJ
        • Recruiting
        • Frimley Park Hospital
        • Contact:
      • Gloucester, United Kingdom, GL1 3NN
        • Recruiting
        • Gloucestershire Royal Hospital
        • Contact:
      • Liverpool, United Kingdom, L7 8XP
      • London, United Kingdom, EC1V 2PD
        • Recruiting
        • Moorfields Eye Hospital
        • Contact:
      • London, United Kingdom, NW1 5QH
      • Manchester, United Kingdom, M13 9WL
      • Newcastle, United Kingdom, NE1 4LP
      • Nottingham, United Kingdom, NG7 2UH
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospital Southampton
        • Contact:
      • Sunderland, United Kingdom, SR2 9HP
        • Recruiting
        • Sunderland Eye Infirmary
        • Contact:
  • United States
    • California
      • Glendale, California, United States, 91204
        • Recruiting
        • Global Research Management
      • Mountain View, California, United States, 94040
        • Not yet recruiting
        • Northern California Retina Vitreous Associates
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Not yet recruiting
        • Midwest Eye Institute
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Not yet recruiting
        • Mid Atlantic Retina Specialists
    • Nevada
      • Reno, Nevada, United States, 89506
        • Not yet recruiting
        • Sierra Eye Associates
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Verum Research LLC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Not yet recruiting
        • Retina Service of Wills Eye Hospital
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Retina Research Institute of Texas
      • Plano, Texas, United States, 75075
        • Not yet recruiting
        • Texas Retina Associates
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • 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

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

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

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

Complement Therapeutics

Investigators

  • 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)

February 7, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

March 22, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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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