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Home OCT Fluid Visualization Agreement Study

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: NCT04907409
Recruitment Status : Recruiting
First Posted : May 28, 2021
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Notal Vision Inc.

Brief Summary:
This is a single arm study of home monitoring with the NVHO for 5 weeks with office visits at enrollment, Week 1 and Week 5 (Exit Visit) and, when applicable, Interim Visit(s) triggered by ongoing review by the Reading Center. The study will enroll subjects diagnosed with NV-AMD in at least one eye with attention to the proportion of eyes with IRF and/or SRF. The enrolled eligible subjects will be instructed to self-image the study eye(s) once daily for 5 weeks using a NVHO device at home with scheduled in-office examinations at Week 1, Week 5 and Interim Visits, when applicable, with additional in-office Cirrus volume scans acquired at these office visits. The self-imaging data on the NVHO will be automatically uploaded to the Notal Health Cloud and from there the reconstructed volume scans will sent to the study database.

Condition or disease
Neovascular Age-related Macular Degeneration

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Home OCT Fluid Visualization Agreement Study at Multiple Retinal Clinics With Placement of One Home OCT Device in the Home of Each NV-AMD Subject in the US for 5 Weeks
Actual Study Start Date : June 17, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : August 30, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Positive percent agreement [ Time Frame: 1 month following reading center grading completion ]
    Positive percent agreement (PPA) of fluid status when comparing the fluid status in the central 3mm X 3mm of the NVHO volume scan graded by an independent reading center to the fluid status in the central 3mm X 3mm of Cirrus volume scan graded by an independent reading center.

  2. Negative percent agreement [ Time Frame: 1 month following reading center grading completion ]
    Negative percent agreement (NPA) of fluid status when comparing the fluid status in the central 3mm X 3mm of the NVHO volume scan graded by an independent reading center to the fluid status in the central 3mm X 3mm Cirrus volume scan graded by an independent reading center.

  3. Percentage of subjects who successfully completed the setup of the NVHO device [ Time Frame: 5-10 minutes ]
    Percentage of subjects who successfully completed the setup of the NVHO, indicated by the initiation of the tutorial.

  4. Percentage of subjects who Successful completed NVHO self-imaging [ Time Frame: 2-3 minutes ]
    Percentage of subjects who Successful completed NVHO self-imaging, namely a volume macular scan has been captured.


Secondary Outcome Measures :
  1. Percentage of all sessions that were transmission successfully [ Time Frame: 10-15 minutes ]
    Percentage of sessions transmitted successfully to the Notal Health Cloud to the Notal Health Cloud .

  2. Percentage of sessions containing self-imaging that were transmitted successfully [ Time Frame: 10-15 minutes ]
    Percentage of sessions containing self-imaging that were transmitted successfully to the Notal Health Cloud.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult subjects diagnosed with neovascular age-related macular degeneration (NV-AMD) in at least one eye at the time of enrollment.
Criteria

Inclusion Criteria:

  1. Subjects must have the ability to speak, read and understand English.
  2. Ability to understand and agree to contents of informed consent either in writing or verbally.
  3. Age 55 or older at the Enrollment Visit.
  4. Adults diagnosed with NV-AMD in at least one eye based on the subject's medical record. Fellow eyes diagnosed with dry AMD may be included as secondary eyes to a primary eye diagnosed with NV-AMD.

    Note: eyes whit other pathologies including pseudocysts, outer retinal tabulations, pigments epithelial, detachments, hemorrhage, sub retinal hyper reflective material (SHRM), geographic atrophy and sub RPE, hypo reflective areas can be enrolled.

  5. Best corrected Visual Acuity of 20/320 or better in eyes that will perform self-imaging.
  6. Available and willing to set up a device and conduct self-imaging at their home.

Exclusion Criteria:

  1. Anti-VEGF treatment for NV-AMD in the study eye(s) at the screening visit.
  2. Any other retinal disease requiring steroidal or anti-VEGF injections.
  3. Prior experience with the NVHO device.

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): NCT04907409


Contacts
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Contact: Theresa Landry, PhD 18174807964 theresa.landry@notalvision.com
Contact: Lisa Sorrells, BS 8179056748 lisa.sorrells@notalvision.com

Locations
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United States, Georgia
Georgia Retina Recruiting
Marietta, Georgia, United States, 30060
Contact: Stephanie Hurst       scampbell@garetina.com   
Contact: Leslie Marcus    770-218-1888    lmarcus@garetina.com   
Principal Investigator: Sri Krishna Mukkamala, MD         
United States, Kentucky
Retina Associates of Kentucky Recruiting
Lexington, Kentucky, United States, 40509
Contact: Diana Holcomb    859-264-2905    dholcomb@retinaky.com   
Contact: Sean Massey    859-264-2905    smassey@retinaky.com   
Principal Investigator: Miguel Busquets, MD         
United States, Maryland
Elman Retina Group, P.A. Recruiting
Glen Burnie, Maryland, United States, 21061
Contact: JoAnn Starr    410-686-3000    Starr@elmanretina.com   
Principal Investigator: Michael J. Elman, MD         
United States, Massachusetts
Ophthalmic Cons. of Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jamie Szczepanski    617-314-2636    jszczepanski@eyeboston.com   
Contact: Sandy Chong    617-314-2627    schong@eyeboston.com   
Principal Investigator: Jeffrey Heier, MD         
United States, Missouri
Pepose Vision Institute/Midwest Vision Research Foundation Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Roxanne Canter    636-534-5126    rcanter@midwestvrf.org   
Principal Investigator: Nancy Holekamp, MD         
United States, Virginia
Wagner Macula & Retina Center Recruiting
Norfolk, Virginia, United States, 23502
Contact: Michael Boboc       mboboc@wagnerretina.com   
Contact: Chris Riebling Riebling    757-390-2433    criebling@wagnerretina.com   
Principal Investigator: Alan L. Wagner Wagner, MD         
Virginia Eye Institute Recruiting
Richmond, Virginia, United States, 23230
Contact: Lea Anderlini    804-287-4250    anderlinil@vaeye.com   
Principal Investigator: Byron S. Ladd, MD         
Sponsors and Collaborators
Notal Vision Inc.
Investigators
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Study Director: Gidi Benyamini, MD Druyanov 5, Tel Aviv Israel
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Responsible Party: Notal Vision Inc.
ClinicalTrials.gov Identifier: NCT04907409    
Other Study ID Numbers: C2021.001
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases