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

NCT05202587 | Completed DMC

• 1 other identifier: C2021.006
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 5

Brief 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). 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.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (7)

• Intra-Retinal Fluid (IRF)

  volume \[nl\] of the Intra-retinal fluid

  5 minutes

• Sub-Retinal Fluid (SRF)

  volume \[nl\] of the Sub-retinal fluid

  5 minutes

• IRF spatial distribution

  frontal view (en-face) of IRF thickness map

  5 minutes

• SRF spatial distribution

  frontal view (en-face) of SRF thickness map

  5 minutes

• IRF area segmentation

  Segmented B-scans of the IRF

  5 minutes

• SRF area segmentation

  Segmented B-scans of the ISRF

  5 minutes

• Mean central retinal thickness

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

  5 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• \. Ability to speak, read and understand English. 2. Ability to understand and agree to contents of informed consent either in writing or verbally.
• \. Adult diagnosed with NV-AMD in at least one eye with or without fluid based on the subject's medical record.
• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Notal Vision Inc.: lead

Study Sites (5)

Brian Joondeph

Lakewood, Colorado, 80228, United States

Location

Florida Retina Institute, PA

Orlando, Florida, 32806, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Tennessee Retina, PC

Nashville, Tennessee, 37203, United States

Location

Strategic Clinical Research Group

Willow Park, Texas, 76087, United States

Location

Study Officials

• Gidi Benyamini

  Notal vision Druyanov 5, Tel Aviv

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2022
• First Posted: January 21, 2022
• Study Start: November 10, 2021
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: February 15, 2023

Record last verified: 2023-02

Locations

US (5)