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

Description

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

Conditions

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

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Dry Age-related Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Glendale

Global Research Management, Glendale, California, United States, 91204

Mountain View

Northern California Retina Vitreous Associates, Mountain View, California, United States, 94040

Carmel

Midwest Eye Institute, Carmel, Indiana, United States, 46290

Hagerstown

Mid Atlantic Retina Specialists, Hagerstown, Maryland, United States, 21740

Reno

Sierra Eye Associates, Reno, Nevada, United States, 89506

Eugene

Verum Research LLC, Eugene, Oregon, United States, 97401

Philadelphia

Retina Service of Wills Eye Hospital, Philadelphia, Pennsylvania, United States, 19107

Abilene

Retina Research Institute of Texas, Abilene, Texas, United States, 79606

Plano

Texas Retina Associates, Plano, Texas, United States, 75075

San Antonio

San Antonio Eye Center, San Antonio, Texas, United States, 78215

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Complement Therapeutics,

Marta Ugarte, PRINCIPAL_INVESTIGATOR, Manchester Royal Eye Hospital

Study Record Dates

2026-12-31