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Retinal NeovascularizationNCT04650672

Daily Testing at Home by NV-AMD Subjects With Notal Home OCT.

An observational study of Retinal Neovascularization, run by Notal Vision Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Retinal Neovascularization
How many people
15 participants
Where
2 sitesUnited States
Study dates
8 Dec 2020to 30 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Ophthalmic Cons. of Boston

    Boston, Massachusetts, 02114

  • Pepose Vision Institute

    St Louis, Missouri, 63017

Other trials in United States

About this study

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.

Read the detailed description

Office Visit screening visit:

  1. The patient will be informed concerning the study and sign the Informed Consent Form (ICF) prior to conduct of any study procedures
  2. The following data will be collected for each study subject: a .Subject's DOB (if allowed) or age b. Gender c .Race d. Ethnicity
  3. BCVA on both eyes on the day of the visit
  4. 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
  5. Both eyes of the subject that meet all screening criteria will be enrolled
  6. The following data will be collected for the study eye(s):
  7. Qualifying diagnosis for the study eye from the subject's medical record
  8. From the subject's medical record, the presence of other ophthalmic conditions including but not limited to:
  9. Cataract ii. Glaucoma iii. Dry Eye iv. Other macula findings
  10. 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.
  11. 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:

  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 NVDC via phone during standard business hours of 8am - 6pm EST, if needed.
  4. 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,

  1. Day 0: The subject will review the tutorial and will perform one calibration session for each eye.
  2. 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.
  3. 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:

  1. BCVA will be performed on both eyes.
  2. Both eyes of the subject will be imaged, using a Cirrus or Spectralis OCT, and reviewed by the PI to determine fluid status.
  3. Initiate standard of care and treatment, if necessary.
  4. Collect AEs, if applicable.
  5. Subject completes the Notal Home OCT Subject User Questionnaire.
  6. Exit subject from the study.
Keywords
AMD self-scanning Home-OCT
Medical subject headings
Retinal Neovascularization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of successful imaging attempts during daily testing.

    Measured: 90 days

Secondary outcomes (3)
  1. Percentage of eyes successfully completed the set up and calibration

    Measured: 10-15 minutes

  2. 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)

    Measured: 90 days

  3. Percentage of eligible B-scans out of the maximum 88 in each volume scan during daily testing

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Dec 2020
  2. Study start8 Dec 2020
  3. Primary completion4 Aug 2021
  4. Study completion30 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04650672
Sponsor's protocol ID
C2020.004
Status last verified
Nov 2021
First submitted
25 Nov 2020
Last updated
29 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Retinal Neovascularization, run by Notal Vision Inc. at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of successful imaging attempts during daily testing. (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021.

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