ACTIVE_NOT_RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-02-07

Study Completion:2027-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05797896

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.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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	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

Inclusion Criteria

Exclusion 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

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

Contacts and Locations

Principal Investigator

Marta Ugarte

PRINCIPAL_INVESTIGATOR

Manchester Royal Eye Hospital

Study Locations (Sites)

Global Research Management

Glendale, California, 91204

United States

Northern California Retina Vitreous Associates

Mountain View, California, 94040

United States

Midwest Eye Institute

Carmel, Indiana, 46290

United States

Mid Atlantic Retina Specialists

Hagerstown, Maryland, 21740

United States

Sierra Eye Associates

Reno, Nevada, 89506

United States

Verum Research LLC

Eugene, Oregon, 97401

United States

Mid Atlantic Retina

Philadelphia, Pennsylvania, 19610

United States

Retina Research Institute of Texas

Abilene, Texas, 79606

United States

Texas Retina Associates

Plano, Texas, 75075

United States

San Antonio Eye Center

San Antonio, Texas, 78215

United States

Collaborators and Investigators

Sponsor: Complement Therapeutics

Marta Ugarte, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2023-02-07

Study Completion Date2027-07-31

Study Record Updates

Study Start Date2023-02-07

Study Completion Date2027-07-31

Terms related to this study

Keywords Provided by Researchers

Dry Age-related Macular Degeneration
Geographic Atrophy
Retinal Disease
Macular Degeneration
Macular Atrophy
Retinal Degeneration
Eye Diseases
AMD
GA

Additional Relevant MeSH Terms

Dry Age-related Macular Degeneration
Geographic Atrophy
Retinal Disease
Macular Degeneration
Macular Atrophy
Retinal Degeneration
Eye Diseases