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

Sponsor
Complement Therapeutics (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05797896
Collaborator
(none)
250
Enrollment
12
Locations
24
Anticipated Duration (Months)
20.8
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

An observational study to evaluate different biomarkers of subjects with geographic atrophy secondary to age-related macular degeneration

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Prospective, observational study to assess the relationships between circulating levels of complement proteins measured using the Complement Precision Medicine (CPM) Platform, variants in genes and lesion progression in subjects with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD) over a 12-month period

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    A Multicentre, Natural History, Non-interventional Study Evaluating Biomarkers In Participants With Geographic Atrophy(GA) Secondary To Age-Related Macular Degeneration (AMD)
    Actual Study Start Date :
    Feb 7, 2023
    Anticipated Primary Completion Date :
    Feb 6, 2025
    Anticipated Study Completion Date :
    Feb 6, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Levels of complement proteins [12 months]

      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 Outcome Measures

    1. CRP Levels [12 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

    2. Geographic Atrophy [12 months]

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

    3. Choroidal Blood Flow [12 months]

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

    4. Genetics [12 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    1. Clinical diagnosis of GA due to AMD (present in one or both eyes) as confirmed by fundoscopy and/or any pre-existing retinal imaging at Screening

    2. Willing and able to provide written informed consent

    3. Male or female aged 18 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. Any ocular pathology which would impede clear imaging of the macula, e.g. intra-ocular opacities

    3. Macular changes from causes other than AMD

    4. Diabetic retinopathy (presence of diabetes with no retinopathy is not an exclusion criteria) Any physical condition which would prevent the participant from undertaking the imaging procedures

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Belfast City Hospital Belfast United Kingdom BT9 7AB
    2 Bradford Royal Infirmary Bradford United Kingdom BD9 6TB
    3 Frimley Park Hospital Frimley United Kingdom GU16 7UJ
    4 Gloucestershire Royal Hospital Gloucester United Kingdom GL1 3NN
    5 Leicester Royal Infirmary Leicester United Kingdom LE1 5WW
    6 Liverpool Hospital Liverpool United Kingdom L7 8XP
    7 Moorfields Eye Hospital London United Kingdom EC1V 2PD
    8 Manchester Royal Eye Hospital Manchester United Kingdom M13 9WL
    9 Newcastle Hospital Newcastle United Kingdom NE1 4LP
    10 Nottingham City Hospital Nottingham United Kingdom NG7 2UH
    11 University Hospital Southampton Southampton United Kingdom SO16 6YD
    12 Sunderland Eye Infirmary Sunderland United Kingdom SR2 9HP

    Sponsors and Collaborators

    • Complement Therapeutics

    Investigators

    • Principal Investigator: Marta Ugarte, Manchester Royal Eye Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Complement Therapeutics
    ClinicalTrials.gov Identifier:
    NCT05797896
    Other Study ID Numbers:
    • IGS01
    First Posted:
    Apr 4, 2023
    Last Update Posted:
    Apr 4, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Degeneration
    Eye Diseases
    Geographic Atrophy
    Retinal Diseases
    Retinal Degeneration
    Anetoderma
    Atrophy

    Study Results

    No Results Posted as of Apr 4, 2023