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The purpose of this study is to evaluate the ability of subjects with NV-AMD to perform sequential daily self-imaging of their eyes with the self-operated Notal Home OCT device in their homes for 90 days without on-site supervision. The study will include up to 15 subjects.
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):
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:
In-Home Phase (Day 0 to Day 90) Following set-up of the Notal Home OCT,
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:
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of successful imaging attempts during daily testing. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of eyes successfully completed the set up and calibration | 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) | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include approximately fifteen (15) subjects diagnosed with NV-AMD in at least one eye with initiation of anti-VEGF treatment within the past 6 months, at treatment intervals 8 weeks or less, in the NV-AMD eye. At least 50% of the subjects in each of the two study sites with active NV-AMD at time of enrollment in at least one eye, defined as presence of intra- and/or subretinal fluid as seen on the office OCT. Approximately 50% of the eyes with fluid will have intra retinal fluid and at approximately 50% will have sub retinal fluid. Eyes may have both types of fluid.
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Heier, MD | Ophthalmic Consultants of Boston, Boston, MA. | Principal Investigator |
| Nancy Holekamp, MD | Pepose Vision Institute, Chesterfield, MO. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Cons. of Boston | Boston | Massachusetts | 02114 | United States | ||
| Pepose Vision Institute |
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| ID | Term |
|---|---|
| D015861 | Retinal Neovascularization |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
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| Percentage of eligible B-scans out of the maximum 88 in each volume scan during daily testing | 90 days |
| St Louis |
| Missouri |
| 63017 |
| United States |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |