- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04650672
Daily Testing at Home by NV-AMD Subjects With Notal Home OCT.
Study Overview
Status
Conditions
Detailed Description
Office Visit screening visit:
- The patient will be informed concerning the study and sign the Informed Consent Form (ICF) prior to conduct of any study procedures
The following data will be collected for each study subject:
a .Subject's DOB (if allowed) or age b. Gender c .Race d. Ethnicity
- BCVA on both eyes on the day of the visit
- Both eyes of the subject will be scanned, non-dilated, with either a commercial Zeiss Cirrus or Heidelberg Engineering Spectralis OCT device with one (1) acceptable volume scan of each eye being obtained
- Both eyes of the subject that meet all screening criteria will be enrolled
The following data will be collected for the study eye(s):
- Qualifying diagnosis for the study eye from the subject's medical record
- From the subject's medical record, the presence of other ophthalmic conditions including but not limited to:
i. Cataract ii. Glaucoma iii. Dry Eye iv. Other macula findings
- The subject will receive a general overview of the self-operation of the Notal Home OCT at the investigational clinic facility by trained study personnel. A Notal Home OCT device is then assigned to the subject.
- The subject will be reminded that the Notal Home OCT will be delivered to their home and instructed to self-image the study eye(s) daily using a Notal Home OCT device at home for 90 days.
Home Set-up with Remote Assistance (Day 0)
Following confirmation of subject eligibility at the Enrollment visit and the subject is enrolled in the study:
- The subject will be contacted by the NVDC to verify their delivery address.
- The device will be delivered to the subject's home, with confirmation sent back to the NVDC.
- Remote support is available by the NVDC via phone during standard business hours of 8am - 6pm EST, if needed.
- The subject will follow the steps detailed in the Set-up Guide included in the box
In-Home Phase (Day 0 to Day 90) Following set-up of the Notal Home OCT,
- Day 0: The subject will review the tutorial and will perform one calibration session for each eye.
- Day 1: The subject will perform the first self-imaging session with the Notal Home OCT on both eyes followed by automated transmission of the scans. This first session will be considered a practice session.
- Days 2-90: The patient will perform one self-imaging session followed by automated transmission on both eyes at home with the Notal Home OCT each day.
If an eye cannot calibrate during 5 separate attempts or fails to test 5 consecutive times, the subject will be notified by the NVDC to discontinue self-imaging this eye. If there is a fellow eye also enrolled in the study, the fellow eye will continue
Weekly Review of Notal Home OCT Images by the PI:
The physician will review patient images on a weekly basis to perform an assessment of daily fluid status and document their observations in the CRF.
Routine Care Visits:
Routine care visits may be conducted at the investigator's discretion. The following procedures will be performed at the routine care visits: BCVA, Spectralis or Cirrus OCT, 3. Initiate treatment, if necessary, and document which anti-VEGF drug is used.
At Office Exit Visit (approximately 90 days after Day 0)
Subjects will return to the clinic for an office visit approximately ninety (90) days after the Day 0 (Home Set-up) Visit. At this visit, the exams will be conducted in the following order:
- BCVA will be performed on both eyes.
- Both eyes of the subject will be imaged, using a Cirrus or Spectralis OCT, and reviewed by the PI to determine fluid status.
- Initiate standard of care and treatment, if necessary.
- Collect AEs, if applicable.
- Subject completes the Notal Home OCT Subject User Questionnaire.
- Exit subject from the study.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Ophthalmic Cons. of Boston
-
-
Missouri
-
Saint Louis, Missouri, United States, 63017
- Pepose Vision Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Ability to speak and understand English with fluency.
- Ability to understand and agree to contents of informed consent either in writing or verbally.
- At least 55 years of age on date of Screening Visit.
- Diagnosed with NV-AMD in at least one eye and initiation of anti-VEGF treatment in that eye.
- At least one enrolled eye per subject had retinal fluid treated with anti-VEGF in the prior 6 months, with a treatment interval of 8 weeks or less.
- Visual Acuity of 20/320 or better.
- Available and willing to conduct daily self-imaging at home for the duration of the trial.
Exclusion Criteria:
- Any other retinal disease in the study eye requiring steroidal or anti-VEGF injections (anti-VEGF injections during the study period must be for NV-AMD).
- Subject's schedule not conducive to completing daily tests at home with the Notal Home OCT device for the duration of the study.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of successful imaging attempts during daily testing.
Time Frame: 90 days
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of eyes successfully completed the set up and calibration
Time Frame: 10-15 minutes
|
10-15 minutes
|
Percentage of volume scans with Manufacturer Image quality Index (MSI) >=2 (in a scale of 0-7, where 2 is a pre-defined acceptable-MSI cutoff)
Time Frame: 90 days
|
90 days
|
Percentage of eligible B-scans out of the maximum 88 in each volume scan during daily testing
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nancy Holekamp, MD, Pepose Vision Institute, Chesterfield, MO.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C2020.004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Retinal Neovascularization
-
Instituto de Olhos de GoianiaUnknownChoroidal Retinal NeovascularizationBrazil
-
Federico II UniversityCompleted
-
Notal Vision Inc.RecruitingRetinal NeovascularizationUnited States
-
Fondation Ophtalmologique Adolphe de RothschildCompletedRetinal NeovascularizationFrance
-
Ophthalmological Association EdelweissCompleted
-
University Hospital, GhentRecruitingMacular Edema | Retinal NeovascularizationBelgium
-
Tianjin Medical UniversityTerminatedThe Mechanism of Retinal Neovascularization of Diabetic | Retinopathy.China
-
University of MelbourneCompletedChoroidal Neovascularization | Retinal Pigment Epithelial DetachmentAustralia
-
Federico II UniversityRecruiting
-
Salutaris Medical Devices, Inc.Active, not recruitingMacular Degeneration, Choroidal NeovascularizationUnited States