Comparing imaging systems for geographic atrophy in macular degeneration
COmparison of Clarus and Optos Ultrawide Field Imaging Systems for Geographic Atrophy (COCO-GA) Protocol
This study is testing which imaging system works best to measure the size of geographic atrophy in people with age-related macular degeneration.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | University of Wisconsin, Madison Academic / other |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT05961332 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the accuracy of different imaging systems in measuring the area of geographic atrophy (GA) in patients with age-related macular degeneration. Participants will undergo a dilated fundus exam and imaging using the Optos ultrawide field fundus autofluorescence and Zeiss Clarus systems, alongside the gold standard Spectralis imaging. The study will take place in a single visit lasting 60-75 minutes, with images assessed by experienced readers to determine which device provides measurements closest to the standard of care.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with an established diagnosis of geographic atrophy due to age-related macular degeneration.
Not a fit: Patients with neovascular age-related macular degeneration or significant media opacity that prevents adequate imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of geographic atrophy measurements, leading to better patient management and treatment outcomes.
How similar studies have performed: While comparative imaging studies exist, this specific comparison of these imaging systems for geographic atrophy is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 50 years or older and may be either male or female and may be of any race * Established diagnosis of GA due to AMD * GA characteristics: GA area of between 1.25 mm² and 23 mm², with seventy percent of eyes having GA area ranging from 2.5 mm² to 17.5 mm². GA may be unifocal or multifocal. GA may be subfoveal or extrafoveal, with twenty-five percent of eyes having subfoveal GA. The presence of concurrent peripapillary atrophy will not exclude subjects from participation * Willing to participate as evidenced by signing the written informed consent Exclusion Criteria: * Unable to tolerate opthalmic imaging * Presence of neovascular AMD on OCT as confirmed by an ophthalmologist * Presence of significant media opacity preventing adequate retinal imaging * Presence of concurrent retinal disease which may confound assessment
Where this trial is running
Madison, Wisconsin
- University of Wisconsin — Madison, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Amitha Domalpally, MD, PhD — University of Wisconsin, Madison
- Study coordinator: Angie Adler
- Email: amadler1@wisc.edu
- Phone: 608-265-7557
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.