Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03688243
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Image Reading Center

Tracking Information
First Submitted Date September 25, 2018
First Posted Date September 28, 2018
Last Update Posted Date January 16, 2019
Actual Study Start Date January 18, 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 14, 2019)
Change in Choroidal Perfusion Deficits at 1 year compared to Baseline [ Time Frame: 1 year time point ]
Assessment of Choriocapillaris perfusion
Original Primary Outcome Measures
 (submitted: September 26, 2018)
Change in Choroidal Perfusion Deficits at 1 year compared to Baseline [ Time Frame: 1 year time point ]
Change History Complete list of historical versions of study NCT03688243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 14, 2019)
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: September 26, 2018)
  • 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 ]
    Compare the automated measurements of drusen volume using the Zeiss algorithm with manual measurements by trained readers
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non Exudative AMD Imaged With SS-OCT
Official Title Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
At baseline or follow up, an optional blood sample for future exploratory genetics analysis will be collected
Sampling Method Non-Probability Sample
Study Population Subjects with intermediate AMD, Geographic Atrophy and nascent Geographic Atrophy.
Condition Dry 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
Other Names:
  • Zeiss PlexElite
  • PlexElite 9000
  • Swept Source OCT
  • Optical Coherence Tomography Angiography
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Device: SS-OCT imaging
  • Cohort 3
    Subjects with GA enrolled in another trial
    Intervention: Device: SS-OCT imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 26, 2018)
450
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jen Tourtellot 1-855-535-BIRC (2472) admin@bostonimagereadingcenter.com
Listed Location Countries Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03688243
Other Study ID Numbers BIRC-01 IMPACT
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Boston Image Reading Center
Study Sponsor Boston Image Reading Center
Collaborators Not Provided
Investigators
Principal Investigator: Nadia Waheed, MD Boston Image Reading Center/Tufts Medical Center
Principal Investigator: Philip Rosenfield, MD, PhD Bascom Palmer Eye Institute
PRS Account Boston Image Reading Center
Verification Date January 2019