Non Exudative AMD Imaged With SS-OCT

Dry Macular Degeneration Clinical Trial

— BIRC-01  

Official title:

Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03688243
• Other study ID #: BIRC-01 IMPACT
• Status: Active, not recruiting
• Start date: January 18, 2018
• Est. completion date: March 2023

Study information

• Verified date: March 2022
• Source: Boston Image Reading Center
• Contact: n/a
• 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:

This is a longitudinal observational study where the investigators will look at 450 subjects, 200 with intermediate AMD in at least one eye, or with AMD in one eye, either early or intermediate, and with late AMD (exudative) in the other eye, and 250 subjects with nGA or GA in at least one eye.

Other known NCT identifiers

• NCT03972800

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 225
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Aged 50 and over

2. 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

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent

Exclusion Criteria:

A subject who meets any of the following criteria will be excluded from the study:

1. Below the age of 50

2. Subjects with exudative AMD in both eyes

3. Eyes with evidence of non-proliferative and proliferative diabetic retinopathy.

4. Presence of confounding ocular diagnosis such as myopia >6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV

5. Subjects unable to give informed consent.

6. 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 Choroidal Perfusion Deficits at 1 year compared to Baseline	Assessment of Choriocapillaris perfusion	1 year time point
Secondary	Pre-existing sub-clinical Macular Neovascularization (MNV)	Presence of abnormal new vessels arising from the Choroid	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 GA measurements	Compare the automated measurements of GA area using the Zeiss algorithm with manual measurements by trained readers	1 year and 2-year time points
Secondary	Structural OCT markers and Genetic Markers	Correlate structural markers on SS-OCT/OCTA with genetic markers of disease	1 year and 2-year time points