Understanding the role of choriocapillaris in dry macular degeneration
Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study
This study is trying to see how the tiny blood vessels in the eye affect the development of dry macular degeneration in older adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 450 (estimated) |
| Sex | All |
| Sponsor | Boston Image Reading Center Industry-sponsored |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT04469140 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of the choriocapillaris (CC) in the development and progression of non-exudative age-related macular degeneration (AMD). By utilizing SS-OCT imaging, researchers will analyze the retinal pigment epithelium (RPE) and choroidal microvasculature to explore their inter-dependence. The findings may help establish the loss of CC as a potential anatomical endpoint for future clinical trials targeting AMD. This study is an extension of an ongoing longitudinal study (NCT03688243).
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with non-exudative intermediate AMD or geographic atrophy in one eye and who have completed the BIRC-01 study.
Not a fit: Patients with exudative AMD in both eyes or those with significant confounding ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved endpoints for clinical trials in treating dry macular degeneration.
How similar studies have performed: Other studies have explored similar imaging techniques in AMD, but this specific approach focusing on the choriocapillaris is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Enrollment in and completion of the BIRC-01 study * Clinic diagnosis of non-exudative iAMD in at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR Clinical diagnosis of early or early/intermediate stage AMD in one eye in the absence of nGA or GA and exudative AMD in the other eye OR clinical diagnosis of GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye which has never been treated with anti-VEGF agents * Willing and able to comply with clinic visits and study-related procedures * Provide signed informed consent Exclusion Criteria: * Subjects with exudative AMD in both eyes * Eyes with evidence of non-proliferative and proliferative diabetic retinopathy. * Presence of confounding ocular diagnosis such as myopia \>6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV * Subjects currently or previously enrolled in other interventional clinical trials in which treatment was administered to the study eye. * Previous vitrectomy or intravitreal injections in the study eye. * Axial length measurement ≥ 26 mm. * Subjects unable to give informed consent. * Subjects who are unable to comply with imaging guidelines
Where this trial is running
Los Angeles, California and 4 other locations
- University of California Los Angeles Doheny Eye Institute — Los Angeles, California, United States (Recruiting)
- Bascom Palmer Eye Institue — Miami, Florida, United States (Recruiting)
- New England Eye Center/Tufts Medical Center — Boston, Massachusetts, United States (Recruiting)
- Vitreous Retina Macular Consultants of NY — New York, New York, United States (Recruiting)
- Melbourne University CERA — East Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Principal investigator: Nadia Waheed, MD — Boston Image Reading Center/Tufts Medical Center
- Study coordinator: Jen Tourtellot
- Email: admin@bostonimagereadingcenter.com
- Phone: 1-855-535-BIRC (2472)
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.