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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04469140




Registration number
NCT04469140
Ethics application status
Date submitted
23/06/2020
Date registered
13/07/2020
Date last updated
13/07/2020

Titles & IDs
Public title
Non Exudative AMD Imaged With SS-OCT- Extension
Scientific title
Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study
Secondary ID [1] 0 0
BIRC-02 IMPACT SWAGGER
Universal Trial Number (UTN)
Trial acronym
BIRC-02
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - SS-OCT imaging

Cohort 1 'IMPACT Cohort' - Subjects with intermediate AMD in both eyes, and at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR subjects with AMD (early or intermediate) diagnosed in one eye and exudative AMD diagnosed in the fellow eye will undergo SS-OCT imaging every 3 months for 2 years

Cohort 2 'SWAGGER Cohort' - Subjects with 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 will undergo SS-OCT imaging every 3 months for 2 years

Cohort 3 - Subjects with GA enrolled in another trial


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

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
1-year and 2-year time points
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
1-year and 2-year time points
Secondary outcome [2] 0 0
Automated Drusen Volume measurements - Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers
Timepoint [2] 0 0
1-year and 2-year time points
Secondary outcome [3] 0 0
Automated Geography Atrophy measurements - Compare the automated measurements of Geography Atrophy area using the Zeiss algorithm with manual measurements by trained readers
Timepoint [3] 0 0
1-year and 2-year time points
Secondary outcome [4] 0 0
Choroidal Thickness (millimeters) - Correlate Choroidal Thickness measurements (millimeters) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates
Timepoint [4] 0 0
1-year and 2-year time points
Secondary outcome [5] 0 0
Choroidal Vascularity Index (percentage) - Correlate Choroidal Vascularity Index (percentage) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates
Timepoint [5] 0 0
1-year and 2-year time points

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne University CERA - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
New York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boston Image Reading Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT04469140
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nadia Waheed, MD
Address 0 0
Boston Image Reading Center/Tufts Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jen Tourtellot
Address 0 0
Country 0 0
Phone 0 0
1-855-535-BIRC (2472)
Fax 0 0
Email 0 0
admin@bostonimagereadingcenter.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04469140