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Neovascular Age-related Macular DegenerationNCT05202587

The Evaluation of the Agreement Between the NVHO in the Automatic Fluid Quantification and Cirrus OCT

An observational study of Neovascular Age-related Macular Degeneration, run by Notal Vision Inc. at 5 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

This multi-center study will enroll Adult subjects diagnosed with neo-vascular age-related macular degeneration (NV-AMD) in at least one eye at the time of enrollment. the subject study duration for this study is one day (2-3 hours). Read more about this study

Who is it for?
Ages 18 years and older
How many people
386 participants
Where
5 sitesUnited States
Study dates
10 Nov 2021to 12 Jan 2023
How long will I take part?
1 Day
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
  • No healthy volunteers
  • Adult, Older adult

Study population: The study will enroll approximately 140 AMD patients diagnosed with NV-AMD presenting with IRF and 140 AMD patients presenting with SRF in at least one eye at the time of enrollment, and 20 eyes with no fluid for a total of 300 subjects

Who may be able to join

  • 1. Ability to speak, read and understand English. 2. Ability to understand and agree to contents of informed consent either in writing or verbally.
  • 3. Adult diagnosed with NV-AMD in at least one eye with or without fluid based on the subject's medical record.
  • 4. Best corrected Visual Acuity of 20/320 or better in the study eye. 5. Available and willing to conduct Cirrus imaging and NVHO self-imaging in a clinic environment.
  • Note: Eyes with other pathologies including pseudocysts, outer retinal tubulations, pigment epithelial detachments, hemorrhage, subretinal hyper-reflective material (SHRM), geographic atrophy, sub-retinal pigment epithelium (RPE) hypo-reflective areas, epiretinal membrane (ERM), macular hole, and hyperreflective retinal spots (Foci) can be enrolled.

Who cannot join

  • 1. Any other retinal disease requiring steroid or anti-VEGF injections. 2. Cirrus scan during screening with Signal Strength <6. 3. Dry AMD in study eye.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Brian Joondeph

    Lakewood, Colorado, 80228

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203

  • Florida Retina Institute, PA

    Orlando, Florida, 32806

  • Strategic Clinical Research Group

    Willow Park, Texas, 76087

Other trials in United States

About this study

Official title: The Evaluation of the Agreement and Precision of the Notal Vision Home OCT in the Automatic Fluid Quantification in Patients With NV-AMD.

This multi-center study will enroll Adult subjects diagnosed with neo-vascular age-related macular degeneration (NV-AMD) in at least one eye at the time of enrollment. the subject study duration for this study is one day (2-3 hours). Each study site will have two NVHO devices and one Cirrus 5000 and the patients will be scand on the two NVHO devices and one Cirrus device as a part of the study flow. At the Study Visit, fluid must be present in approximately 280 study eyes and fluid must be absent from 20 study eyes. Each subject will only have one study eye. The fluid status will be determined by the investigator while reviewing an acceptable screening Cirrus OCT volume scan.

Read the detailed description

Screening will include refraction, best corrected visual acuity and Cirrus OCT. Subjects will receive a general overview of the self-operation of the NVHO system. The general overview will include written material and a verbal explanation.

If only one eye qualifies for enrollment, that eye will be assigned as the study eye. If both eyes are eligible, the study eye will be assigned according to a randomization schedule unless the fluid type (IRF or SRF) between eyes is different, in which case the randomization can be overridden at the discretion of an Investigator to fulfill the required sample size of the fluid type. volume scans will be calculated for each enrolled eligible study eye Once the study eye has been identified, the subject will be assigned to either perform a Cirrus OCT first or perform self-imaging on a NVHO first. The order between the Cirrus OCT or the NVHO will be assigned according to a randomization schedule. Whichever is assigned first will be completed followed by the second assigned device.

Cirrus OCT Scans:

When the study eye is assigned to perform the Cirrus OCT, the study eye will be scanned, non-dilated with a Cirrus 5000 OCT device, up to 4 times with the objective of obtaining two acceptable volume scans for the study eye. The enrolled subjects that are randomized to have Cirrus volume scans first will be discontinued before NVHO self-imaging if two acceptable Cirrus volume scans cannot be obtained.

NVHO Scans:

When the study eye is assigned to perform the NVHO OCT scans, the subject will:

  1. Be escorted to a separate room, with two NVHO devices.
  2. Be given an explanation of the procedure of self-imaging 4 repeated NVHO volume scans from each of the two NVHO devices. The order of the two NVHO devices will be assigned according to a randomization schedule.
  3. Perform a tutorial on the better seeing eye as indicated by the subject on the first randomly assigned device, even if this better seeing eye is not the study eye.
  4. Perform a successful calibration on the study eye in up to 3 attempts on the first NVHO device. In case of 3 repeated failures in calibration, the participation of the subject in the study will be terminated.
  5. Self-image the study eye 4 times on the first NVHO device (in order to have at least 3 images eligible for NOA fluid quantification), with a short break between scans.
  6. When 4 images are obtained on the first device, perform a successful calibration on the second NVHO device with the study eye in up to 3 attempts. In case of 3 repeated failures in calibration, the participation of the subject in the study will be terminated.
  7. Self-image the study eye 4 times on the second NVHO device, with a short break between scans.
  8. When 4 scans are obtained on both NVHO devices, scanning is completed.

Subject Exit from the Study:

After the subject has completed all the study procedures, the subject will be discontinued from the study. Subjects may withdraw voluntarily from the study at any time.

What is being measured

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

  1. Intra-Retinal Fluid (IRF)

    volume [nl] of the Intra-retinal fluid

    Measured: 5 minutes

  2. Sub-Retinal Fluid (SRF)

    volume [nl] of the Sub-retinal fluid

    Measured: 5 minutes

  3. IRF spatial distribution

    frontal view (en-face) of IRF thickness map

    Measured: 5 minutes

  4. SRF spatial distribution

    frontal view (en-face) of SRF thickness map

    Measured: 5 minutes

  5. IRF area segmentation

    Segmented B-scans of the IRF

    Measured: 5 minutes

  6. SRF area segmentation

    Segmented B-scans of the ISRF

    Measured: 5 minutes

  7. Mean central retinal thickness

    Retina thickness (µ) in 5 central ETDRS grid fields (Total, superior, temporal, inferior, nasal, and central)

    Measured: 5 minutes

Timeline

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

  1. First posted21 Jan 2022
  2. Study start10 Nov 2021
  3. Primary completion12 Jan 2023
  4. Study completion12 Jan 2023

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
386 participants (actual)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT05202587
Sponsor's protocol ID
C2021.006
Status last verified
Feb 2023
First submitted
9 Jan 2022
Last updated
15 Feb 2023
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 5 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 4 inclusion and 1 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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?

Intra-Retinal Fluid (IRF) (time frame: 5 minutes). The study lists 7 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 NCT05202587.

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 15 Feb 2023.

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