Dry Macular DegenerationBIRC-01NCT03688243
Non Exudative AMD Imaged With SS-OCT
An observational study of Dry Macular Degeneration, run by Boston Image Reading Center at 5 sites in 2 countries.
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?
- Ages 50 years and older
- Conditions the study is for
- Dry Macular Degeneration
- What is being tested?
- SS-OCT imaging
- Type of treatment
- Medical device
- How many people
- 225 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 18 Jan 2018to Mar 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with intermediate AMD, Geographic Atrophy and nascent Geographic Atrophy.
Who may be able to join
- Aged 50 and over
- 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
- A subject who meets any of the following criteria will be excluded from the study:
- Below the age of 50
- 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 unable to give informed consent.
- Subjects who are unable to comply with imaging guidelines
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
New England Eye Center/Tufts Medical Center
Boston, Massachusetts, 02111
University of California Los Angeles Doheny Eye Institute
Los Angeles, California, 91105
Bascom Palmer Eye Institue
Miami, Florida, 33136
Vitreous Retina Macular Consultants of NY
New York, New York, 10022
About this study
Official title: Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography
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
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.
- Conditions
- Dry Macular Degeneration
- 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 group | Role | What 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 3 | Subjects 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.
Change in Choroidal Perfusion Deficits at 1 year compared to Baseline
Assessment of Choriocapillaris perfusion
Measured: 1 year time point
Secondary outcomes (4)
Pre-existing sub-clinical Macular Neovascularization (MNV)
Presence of abnormal new vessels arising from the Choroid
Measured: 1 year and 2-year time points
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
Automated GA measurements
Compare the automated measurements of GA area using the Zeiss algorithm with manual measurements by trained readers
Measured: 1 year and 2-year time points
Structural OCT markers and Genetic Markers
Correlate structural markers on SS-OCT/OCTA with genetic markers of disease
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.
- First posted28 Sep 2018
- Study start18 Jan 2018
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Image Reading Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nadia Waheed, MD, Principal investigator, Boston Image Reading Center/Tufts Medical CenterPhilip Rosenfield, MD, PhD, Principal investigator, Bascom Palmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688243
- Sponsor's protocol ID
- BIRC-01 IMPACT
- Acronym
- BIRC-01
- Status last verified
- Mar 2022
- First submitted
- 25 Sep 2018
- Last updated
- 10 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT03688243
- Acronym / sponsor ID
- BIRC-01 / BIRC-01 IMPACT
- Conditions
- Dry Macular Degeneration
- Keywords
- AMD, early AMD, intermediate AMD, Geographic Atrophy, nascent GA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Boston Image Reading CenterIndustry (pharma, biotech, devices)
- Study start
- 18 Jan 2018 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 'IMPACT Cohort' | – | Device: SS-OCT imagingSubjects 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' | – | Device: SS-OCT imagingSubjects 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 | – | Device: SS-OCT imagingSubjects with GA enrolled in another trial |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with intermediate AMD, Geographic Atrophy and nascent Geographic Atrophy.
Key inclusion criteria (4 listed)
- Aged 50 and over
- 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
Key exclusion criteria (7 listed)
- Below the age of 50
- 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 unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SS-OCT imagingAlso: Zeiss PlexElite, PlexElite 9000, Swept Source OCT, Optical Coherence Tomography AngiographyAll subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument | Device | Cohort 1 'IMPACT Cohort', Cohort 2 'SWAGGER Cohort', Cohort 3 |
Primary outcome
Change in Choroidal Perfusion Deficits at 1 year compared to Baseline
Time frame: 1 year time point
Assessment of Choriocapillaris perfusion
4 secondary outcomes
Pre-existing sub-clinical Macular Neovascularization (MNV)
Time frame: 1 year and 2-year time points
Automated Drusen Volume measurements
Time frame: 1 year and 2-year time points
Automated GA measurements
Time frame: 1 year and 2-year time points
Structural OCT markers and Genetic Markers
Time frame: 1 year and 2-year time points
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Waheed, MD principal investigator
Boston Image Reading Center/Tufts Medical Center
Philip Rosenfield, MD, PhD principal investigator
Bascom Palmer Eye Institute
5 sites in 2 countries: see every site and its status.
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 7 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Choroidal Perfusion Deficits at 1 year compared to Baseline (time frame: 1 year time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.