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Neovascular Age-related Macular DegenerationNCT05281042

Home OCT Repeatability and Reproducibility of Automatic Fluid Quantification Study

An observational study of Neovascular Age-related Macular Degeneration, run by Notal Vision Inc. at 1 site 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 study will enroll up to 30 AMD patients diagnosed with NV-AMD in at least one eye at the time of enrollment. At the Study Visit, fluid must be present in at least one eye of the subjects. If only one eye qualifies for enrollment, that will be assigned as the study eye. Read more about this study

Who is it for?
Ages 18 years and older
How many people
20 participants
Where
1 siteUnited States
Study dates
13 Sep 2021to 5 Jan 2022
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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: 30 AMD patients diagnosed with NV-AMD in at least one eye at the time of enrollment. At the Study Visit, fluid must be present in at least one eye of the subjects. If only one eye qualifies for enrollment, that will be assigned as the study eye. If both eyes are eligible, the study eye will be assigned according to a randomization schedule. Only one eye of each subject will be enrolled in the study. All subjects will be enrolled at one 1 site in the United States.

Who may be able to join

  • Ability to speak, read and understand English.
  • Ability to understand and agree to contents of informed consent in writing or verbal.
  • Adult diagnosed with NV-AMD in at least one eye based on the subject's medical record.
  • Fluid presence in the study eye per the PI review of Screening commercial OCT.
  • Best corrected Visual Acuity of 20/320 or better in the study eye.
  • Available and willing to conduct self-scanning in the office

Who cannot join

  • Any other retinal disease requiring steroidal or anti-VEGF injections.
  • Dilated pupils

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Elman Retina Group

    Glen Burnie, Maryland, 21061

Other trials in United States

About this study

The study will enroll up to 30 AMD patients diagnosed with NV-AMD in at least one eye at the time of enrollment. At the Study Visit, fluid must be present in at least one eye of the subjects. If only one eye qualifies for enrollment, that will be assigned as the study eye. If both eyes are eligible, the study eye will be assigned according to a randomization schedule. Only one eye of each subject will be enrolled in the study. All subjects will be enrolled at 1 site in the United States. Subjects must meet all inclusion and no exclusion criteria.

Read the detailed description

Description of Study Procedures and In-Office Visit:

Enrollment/Screening:

At the Enrollment/ Screening Visit, the exams will be conducted in the following order:

  1. 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:
  3. Subject's DOB
  4. Gender
  5. Number and type of injections and last injection date
  6. The following data will be collected for the study eye:
  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, e.g., epi retinal membrane, macular hole, vitreo-macular traction (VMT)
  10. Refraction correction
  11. Snellen BCVA on both eyes on the day of the visit.
  12. Selecting the study eye:
  13. Both eyes of the subject will be scanned, non-dilated, with a Zeiss Cirrus OCT device to get an acceptable single volume scan per eye. Scanning pattern to be used: Macular cube, 6X6mm, 128 B-scans per volume scan
  14. The PI/CoPI will read the Zeiss Cirrus OCT scans of both eyes and will grade each eye for the presence/absence of SRF and/or IRF in the retina
  15. The eye with SRF and/or IRF will be set as the study eye. In case both eyes were graded as fluid-present, the study eye will be set randomly
  16. The Zeiss Cirrus OCT scan of the study eye will be part of the study analysis

NOTE: Any planned treatment for NV-AMD should be administered after completion of all study-related scans

OCT Scans:

  1. The study eye of the subject will be scanned once, non-dilated, with a Zeiss Cirrus OCT device to get an acceptable single volume scan of the study eye in each repetition. Scanning pattern to be used: Macular cube, 6X6mm, 128 B-scans per volume scan
  2. Following the Zeiss Cirrus OCT scans, the subject will be placed in a room with the Notal OCT V3.0 device which has been set up by a technician.
  3. Notal OCT V3.0 scans
  4. The technician will register the subject using the touchscreen of the Notal OCT V3.0 device and the assigned Subject ID.
  5. On the first Notal OCT V3.0 device the subject will perform a self-tutorial.
  6. The technician will set the first Notal OCT V3.0 for self-scan of the study eye. The subject will perform the tutorial on the eye with better vision, based on the subject's subjective decision, even if that eye is not the study eye. Then, the subject will perform on the first device- a calibration, and 5 volume scans.
  7. The technician will set the second device for self-scans of the study eye. The subject will perform calibration and 5 volume scans.
  8. The subject will be able to rest 1-2 minutes between self-scans
  9. Collect AEs, if applicable.
  10. Exit the subjects from the study.

What is being measured

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

  1. Notal Home OCT Total Retinal Fluid (TRF) amount measured by NOA

    volume [nl] of the TRF

    Measured: 5 minutes

  2. Notal Home OCT Intra-Retinal Fluid (IRF) amount measured by NOA

    volume [nl] of the IRF

    Measured: 5 minutes

  3. Notal Home OCT Sub-Retinal Fluid (SRF) amount measured by NOA

    volume [nl] of the SRF

    Measured: 5 minutes

  4. Zeiss Cirrus OCT Total Retinal Fluid (TRF) amount measured by a human reader

    volume [nl] of the TRF

    Measured: 5 minutes

  5. Zeiss Cirrus OCT Intra-Retinal Fluid (IRF) amount measured by a human reader

    volume [nl] of the IRF

    Measured: 5 minutes

  6. Zeiss Cirrus OCT Sub-Retinal Fluid (SRF) amount measured by a human reader

    volume [nl] of the SRF

    Measured: 5 minutes

Secondary outcomes (1)

  1. Subjects who completed self-scanning on the Notal Home OCT, following a self-tutorial.

    Number of subjects and percentage of subjects who completed self-scanning on the Notal Home OCT, following a self-tutorial.

    Measured: 5 minuts

Timeline

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

  1. First posted15 Mar 2022
  2. Study start13 Sep 2021
  3. Primary completion30 Nov 2021
  4. Study completion5 Jan 2022

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05281042
Sponsor's protocol ID
C2021.002
Status last verified
Feb 2022
First submitted
6 Mar 2022
Last updated
5 Apr 2022
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 Neovascular Age-related Macular Degeneration, run by Notal Vision Inc. at 1 site 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 6 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 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Notal Home OCT Total Retinal Fluid (TRF) amount measured by NOA (time frame: 5 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05281042.

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 5 Apr 2022.

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