AzTrials
AzTrials

Dry Macular DegenerationBIRC-02NCT04469140

Non Exudative AMD Imaged With SS-OCT- Extension

An observational study of Dry Macular Degeneration, run by Boston Image Reading Center at 5 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Dry Macular Degeneration
What is being tested?
SS-OCT imaging
Type of treatment
Medical device
How many people
450 participants
Where
5 sitesin 2 countries
Study dates
18 Jan 2020to Aug 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Subjects with intermediate AMD, Geographic Atrophy and nascent Geographic Atrophy and who have completed the BIRC-01 study

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

5 sites in 2 countries.

Jen Tourtellot contact

1-855-535-BIRC (2472)

admin@bostonimagereadingcenter.com

5 sites in 2 countries

United States4 sites, 4 recruiting

  • New England Eye Center/Tufts Medical Center

    Boston, Massachusetts, 02111

    Nancy Gee, MPH

    Michelle Liang, MD

    Recruiting

  • University of California Los Angeles Doheny Eye Institute

    Los Angeles, California, 91105

    Janett Mendez

    SriniVas Sadda, MD

    Recruiting

  • Bascom Palmer Eye Institue

    Miami, Florida, 33136

    Monica Arango

    Philip J Rosenfeld, MD, PhD

    Recruiting

  • Vitreous Retina Macular Consultants of NY

    New York, New York, 10022

    Renata Salgado

    Bailey Freund, MD

    Recruiting

Other trials in United States

Australia1 site, 1 recruiting

  • Melbourne University CERA

    East Melbourne, Victoria, 3002

    Emily Caruso

    Robyn Guymer, MD

    Recruiting

Other trials in Australia

About this study

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

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.

Read the detailed 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).

Being tested
SS-OCT imaging
Keywords
AMD, Early AMD, Intermediate AMD, Geographic Atrophy, Nascent GA
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SS-OCT imagingDevice

    Also called Zeiss PlexElite, PlexElite 9000, Swept Source OCT, Optical Coherence Tomography Angiography

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

Study groups in NCT04469140
Study groupRoleWhat they receive
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
Receives: Device: SS-OCT imaging
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
Receives: Device: SS-OCT imaging
Cohort 3Subjects with GA enrolled in another trial
Receives: Device: SS-OCT imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1-year and 2-year time points

Secondary outcomes (5)

  1. 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

    Measured: 1-year and 2-year time points

  2. Automated Drusen Volume measurements

    Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers

    Measured: 1-year and 2-year time points

  3. Automated Geography Atrophy measurements

    Compare the automated measurements of Geography Atrophy area using the Zeiss algorithm with manual measurements by trained readers

    Measured: 1-year and 2-year time points

  4. Choroidal Thickness (millimeters)

    Correlate Choroidal Thickness measurements (millimeters) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates

    Measured: 1-year and 2-year time points

  5. Choroidal Vascularity Index (percentage)

    Correlate Choroidal Vascularity Index (percentage) with Age related Macular Degeneration (AMD) progression/Geographic Atrophy growth rates

    Measured: 1-year and 2-year time points

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2020
  2. Study start18 Jan 2020
  3. Primary completionAug 2025 (estimated)
  4. Study completionAug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04469140
Sponsor's protocol ID
BIRC-02 IMPACT SWAGGER
Acronym
BIRC-02
Status last verified
Mar 2022
First submitted
23 Jun 2020
Last updated
10 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Macular Degeneration, run by Boston Image Reading Center at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jen Tourtellot (1-855-535-BIRC (2472), admin@bostonimagereadingcenter.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Percentage of Choroidal Perfusion Deficits at 1 year compared to Baseline (time frame: 1-year and 2-year time points). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04469140.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in