Non Exudative AMD Imaged With SS-OCT- Extension

Dry Macular Degeneration Clinical Trial

— BIRC-02  

Official title:

Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04469140
• Other study ID #: BIRC-02 IMPACT SWAGGER
• Status: Recruiting
• Start date: January 18, 2020
• Est. completion date: August 2025

Study information

• Verified date: March 2022
• Source: Boston Image Reading Center
• Contact: Jen Tourtellot
• Phone: 1-855-535-BIRC (2472)
• Email: admin[@]bostonimagereadingcenter.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials.

Description:

The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials. This is an extension of a currently ongoing longitudinal observational study (BIRC-01) (NCT03688243).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Macular Degeneration
• Geographic Atrophy
• Macular Degeneration

Intervention

Device:
• SS-OCT imaging
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument

Locations

Country	Name	City	State
Australia	Melbourne University CERA	East Melbourne	Victoria
United States	New England Eye Center/Tufts Medical Center	Boston	Massachusetts
United States	University of California Los Angeles Doheny Eye Institute	Los Angeles	California
United States	Bascom Palmer Eye Institue	Miami	Florida
United States	Vitreous Retina Macular Consultants of NY	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boston Image Reading Center

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline	Compare the percentage of choroidal perfusion deficits as measured using automated algorithms	1-year and 2-year time points
Secondary	Pre-existing and new sub-clinical Macular Neovascularization (MNV)	Identify the number of abnormal new vessels arising from the Choroid at Baseline, 1-year and 2-year time points	1-year and 2-year time points
Secondary	Automated Drusen Volume measurements	Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers	1-year and 2-year time points
Secondary	Automated Geography Atrophy measurements	Compare the automated measurements of Geography Atrophy area using the Zeiss algorithm with manual measurements by trained readers	1-year and 2-year time points
Secondary	Choroidal Thickness (millimeters)	Correlate Choroidal Thickness measurements (millimeters) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates	1-year and 2-year time points
Secondary	Choroidal Vascularity Index (percentage)	Correlate Choroidal Vascularity Index (percentage) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates	1-year and 2-year time points