Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04907409 |
| Other study ID # |
C2021.001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 17, 2021 |
| Est. completion date |
August 30, 2022 |
Study information
| Verified date |
January 2022 |
| Source |
Notal Vision Inc. |
| Contact |
Theresa Landry, PhD |
| Phone |
18174807964 |
| Email |
theresa.landry[@]notalvision.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
The objectives of this study are to (1) evaluate the agreement, via positive percent
agreement (PPA) and negative percent agreement (NPA), between OCT images captured by the NVHO
and by the Zeiss Cirrus HD-OCT in the visualization of fluid as identified by a RC, in the
central 10 degrees of the macula of NV-AMD patients, and (2) evaluate the ability of subjects
diagnosed with NV-AMD to set up the device and self-image their eyes at home with the NVHO
device (rate of successful imaging attempts).Description of Study Visits and Procedures:
Enrollment Visit:
At this visit, the exams will be conducted in the following order:
1. Subject will be informed concerning the study and sign the Informed Consent Form (ICF)
prior to the conduct of any study procedures.
2. The following data will be collected for each study subject:
1. Subject's date of birth (DOB) (if allowed) or age
2. Gender
3. Race
4. Ethnicity
5. Level of education
3. Eye exams, including Snellen BCVA and subjective symptoms (visual distortions, blurry
vision, and scotoma), will be performed on both eyes on the day of the visit.
4. Both eyes of the subject will be imaged using a commercial Zeiss Cirrus OCT using the
6mm X 6mm, 512 X 128 volume scan program, with a maximum of three attempts for each eye
to reach an acceptable image quality per the Cirrus User's Guide and reviewed by the PI
to determine fluid status.
5. One or both eye(s) of the subject that meets all screening criteria, including having a
diagnosis of NV-AMD in at least one eye previously or at the enrolment visit, will be
enrolled in the study.
- Subjects who do not meet all screening criteria will be deemed a screen failure and
will be exited from the study.
- Study eyes enrolled with fluid in the primary study eye, may receive treatment
during the Week 1 Visit.
- If in the investigator's opinion, the treatment cannot be delayed by approximately
7 days until the Week 1 visit, the subject will be exited from the study as a
Screen Failure.
NOTE: For the subjects with both eyes with NV-AMD, one eye will be randomly selected as
the primary eye during enrollment and the other will be the secondary eye. For subjects
with only one eye with NV-AMD, the fellow eye with dry AMD may be enrolled. For such
subjects, the NV-AMD eye will be the primary eye and the other eye will be the secondary
eye.
6. The following data will be collected for the study eye:
1. Qualifying diagnosis for the study eye from the subject's medical record
2. 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
7. The subject will receive a general overview (including a description of the device and a
review of the NVHO set-up guide) of the self-operation of the NVHO device at the
investigational clinic facility by trained study personnel.
8. The subject will be (1) reminded that the NVHO device will be delivered to their home
and (2) instructed to self-image the study eye(s) once daily using a NVHO device at home
for 5 weeks and the Week 1 and Week 5 visits will be scheduled.
9. Collect AEs, if applicable.
Home Set-up with Remote Assistance (NVHO Setup Period)
Following confirmation of subject eligibility at the Enrollment Visit and the subject is
enrolled in the study:
1. The subject will be contacted by the NVDC to verify their delivery address.
2. The device will be delivered to the subject's home, with confirmation sent back to the
NVDC.
3. Remote support is available by the Notal Vision Diagnostic Clinic (NVDC) via phone
during normal business hours, if needed.
4. The subject will follow the steps detailed in the Set-up Guide included in the box. This
is considered NVHO Setup Period.
Note: A care giver, family member or friend is allowed to assist. At most four
additional calibrations can be performed, on the same day or different consecutive days,
for each study eye if the calibration is not successful.
Note: If an eye cannot calibrate during 5 separate attempts, the subject will be
notified by the NVDC to discontinue self-imaging this eye and NVDC will collect the
corresponding information such as the corresponding eye, self-image discontinuation
reason, and the self-image stopping date. If there is a fellow eye also enrolled in the
study, the fellow eye will continue.
5. Collect AEs, if applicable.
In-Home Phase (Day 1 to Day 35 post NVHO Setup Period) Following set-up of the NVHO,
1. Day 1: The subject will perform the first self-imaging session with the NVHO device on
both eyes followed by automated transmission of the scans. This first session will be
considered a practice session.
2. Days 2-35: The subject will perform one self-imaging session each day on the study
eye(s) with the NVHO device followed by automated transmission. Each scan has a
reliability score provided by the NVHO.
Note: If an eye fails to self-image five consecutive times, the subject will be notified
by the NVDC to discontinue self-imaging this eye and NVDC will collect the corresponding
information such as the corresponding eye, self-image discontinuation reason, and the
self-image stopping date. If there is a fellow eye also enrolled in the study, the
fellow eye will continue.
3. Collect AEs, if applicable, as reported by telephone call or office visit to the
investigational site.
Week 1 (Post NVHO Setup Period)
Subjects will return to the clinic for an office visit one week after the NVHO Setup Period
(Home Set-up). The sponsor will provide transportation upon request. At this visit, the exams
will be conducted in the following order:
1. Eye exams, including Snellen BCVA and subjective symptoms (visual distortions, blurry
vision, and scotoma) will be performed on both eyes on the day of the visit.
2. Both eyes of the subject will be imaged using a commercial Zeiss Cirrus OCT using the
6mmX6mm, 512X128 volume scan program, with a maximum of three attempts for each eye to
reach an acceptable image quality per the Cirrus User's Guide and reviewed by the PI to
determine fluid status.
3. Initiate standard of care and treatment, if necessary.
4. Collect AEs, if applicable. Week 5 / Exit (Post NVHO Setup Period)
Subjects will return to the clinic for an office visit five weeks after the NVHO Setup Period
(Home Set-up). At this visit, the exams will be conducted in the following order:
1. Eye exams, including Snellen BCVA and subjective symptoms (visual distortions, blurry
vision, and scotoma) will be performed on both eyes on the day of the visit.
2. Both eyes of the subject will be imaged using a commercial Zeiss Cirrus OCT using the
6mmX6mm, 512X128 volume scan program, with a maximum of three attempts for each eye to
reach an acceptable image quality per the Cirrus User's Guide and reviewed by the PI to
determine fluid status.
3. Initiate standard of care and treatment, if necessary.
4. Collect AEs, if applicable.
5. Exit subject from the study.
