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Non Exudative AMD Imaged With SS-OCT (BIRC-01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03688243
Recruitment Status : Active, not recruiting
First Posted : September 28, 2018
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
Boston Image Reading Center

Study Description
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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.

Condition or disease Intervention/treatment
Dry Macular Degeneration Device: SS-OCT imaging

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
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Study Type : Observational
Actual Enrollment : 225 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Device: SS-OCT imaging
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
Other Names:
  • Zeiss PlexElite
  • PlexElite 9000
  • Swept Source OCT
  • Optical Coherence Tomography Angiography
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
 Device: SS-OCT imaging
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
Other Names:
  • Zeiss PlexElite
  • PlexElite 9000
  • Swept Source OCT
  • Optical Coherence Tomography Angiography
Cohort 3
Subjects with GA enrolled in another trial
 Device: SS-OCT imaging
All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
Other Names:
  • Zeiss PlexElite
  • PlexElite 9000
  • Swept Source OCT
  • Optical Coherence Tomography Angiography


Outcome Measures
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Primary Outcome Measures :
  1. Change in Choroidal Perfusion Deficits at 1 year compared to Baseline [ Time Frame: 1 year time point ]
    Assessment of Choriocapillaris perfusion


Secondary Outcome Measures :
  1. Pre-existing sub-clinical Macular Neovascularization (MNV) [ Time Frame: 1 year and 2-year time points ]
    Presence of abnormal new vessels arising from the Choroid

  2. Automated Drusen Volume measurements [ Time Frame: 1 year and 2-year time points ]
    Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers

  3. Automated GA measurements [ Time Frame: 1 year and 2-year time points ]
    Compare the automated measurements of GA area using the Zeiss algorithm with manual measurements by trained readers

  4. Structural OCT markers and Genetic Markers [ Time Frame: 1 year and 2-year time points ]
    Correlate structural markers on SS-OCT/OCTA with genetic markers of disease


Biospecimen Retention:   Samples With DNA
At baseline or follow up, an optional blood sample for future exploratory genetics analysis will be collected

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with intermediate AMD, Geographic Atrophy and nascent Geographic Atrophy.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688243


Locations
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United States, California
University of California Los Angeles Doheny Eye Institute
Los Angeles, California, United States, 91105
United States, Florida
Bascom Palmer Eye Institue
Miami, Florida, United States, 33136
United States, Massachusetts
New England Eye Center/Tufts Medical Center
Boston, Massachusetts, United States, 02111
United States, New York
Vitreous Retina Macular Consultants of NY
New York, New York, United States, 10022
Australia, Victoria
Melbourne University CERA
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Boston Image Reading Center
Investigators
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Principal Investigator: Nadia Waheed, MD Boston Image Reading Center/Tufts Medical Center
Principal Investigator: Philip Rosenfield, MD, PhD Bascom Palmer Eye Institute
More Information
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Responsible Party: Boston Image Reading Center
ClinicalTrials.gov Identifier: NCT03688243    
Obsolete Identifiers: NCT03972800
Other Study ID Numbers: BIRC-01 IMPACT
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Boston Image Reading Center:
AMD
early AMD
intermediate AMD
Geographic Atrophy
nascent GA
Additional relevant MeSH terms:
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Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases