Observational study on geographic atrophy in 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)
This study looks at how geographic atrophy from age-related macular degeneration changes over two years and whether certain proteins and genes can help us understand its progression better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Complement Therapeutics Industry-sponsored |
| Locations | 22 sites (Glendale, California and 21 other locations) |
| Trial ID | NCT05797896 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the natural history of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) by assessing the relationships between circulating complement proteins, genetic profiles, and lesion progression over a 24-month period. Participants will undergo clinical evaluations and imaging to confirm their diagnosis and monitor changes in their condition. The study focuses on understanding biomarkers that may influence the progression of GA, providing insights into potential future treatments.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older with a clinical diagnosis of bilateral geographic atrophy due to age-related macular degeneration.
Not a fit: Patients with a history of neovascular (wet) AMD or other significant ocular pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of geographic atrophy progression and lead to improved management strategies for patients with age-related macular degeneration.
How similar studies have performed: While this study focuses on a specific aspect of geographic atrophy, similar observational studies have shown promise in understanding AMD progression and biomarkers.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Glendale, California and 21 other locations
- Global Research Management — Glendale, California, United States (Recruiting)
- Northern California Retina Vitreous Associates — Mountain View, California, United States (Not_yet_recruiting)
- Midwest Eye Institute — Carmel, Indiana, United States (Not_yet_recruiting)
- Mid Atlantic Retina Specialists — Hagerstown, Maryland, United States (Not_yet_recruiting)
- Sierra Eye Associates — Reno, Nevada, United States (Not_yet_recruiting)
- Verum Research LLC — Eugene, Oregon, United States (Recruiting)
- Retina Service of Wills Eye Hospital — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- Retina Research Institute of Texas — Abilene, Texas, United States (Recruiting)
- Texas Retina Associates — Plano, Texas, United States (Not_yet_recruiting)
- San Antonio Eye Center — San Antonio, Texas, United States (Recruiting)
- Belfast City Hospital — Belfast, United Kingdom (Recruiting)
- Bradford Royal Infirmary — Bradford, United Kingdom (Recruiting)
- Frimley Park Hospital — Frimley, United Kingdom (Recruiting)
- Gloucestershire Royal Hospital — Gloucester, United Kingdom (Recruiting)
- Liverpool Hospital — Liverpool, United Kingdom (Recruiting)
- Moorfields Eye Hospital — London, United Kingdom (Recruiting)
- Western Eye Hospital — London, United Kingdom (Recruiting)
- Manchester Royal Eye Hospital — Manchester, United Kingdom (Recruiting)
- Newcastle Hospital — Newcastle, United Kingdom (Recruiting)
- Nottingham City Hospital — Nottingham, United Kingdom (Recruiting)
- University Hospital Southampton — Southampton, United Kingdom (Recruiting)
- Sunderland Eye Infirmary — Sunderland, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Marta Ugarte — Manchester Royal Eye Hospital
- Study coordinator: Marta Ugarte
- Email: marta.ugarte@mft.nhs.uk
- Phone: 0161 701 2589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.