Recruiting

Observational Study

Sponsor:

Notal Vision Inc.

Code:

NCT04907409

Conditions

Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

This is a single arm study of home monitoring with the NVHO for 5 weeks with office visits at enrollment, Week 1 and Week 5 (Exit Visit) and, when applicable, Interim Visit(s) triggered by ongoing review by the Reading Center. The study will enroll subjects diagnosed with NV-AMD in at least one eye with attention to the proportion of eyes with IRF and/or SRF. The enrolled eligible subjects will be instructed to self-image the study eye(s) once daily for 5 weeks using a NVHO device at home with scheduled in-office examinations at Week 1, Week 5 and Interim Visits, when applicable, with additional in-office Cirrus volume scans acquired at these office visits. The self-imaging data on the NVHO will be automatically uploaded to the Notal Health Cloud and from there the reconstructed volume scans will sent to the study database.

Conditions

Neovascular Age-related Macular Degeneration

Study ID

NCT04907409

Start date

Jun 17, 2021

Status verified date

Jan, 2022

Completion date

Aug 30, 2022

Anticipated

Primary completion date

Jul 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Subjects must have the ability to speak, read and understand English.
2. Ability to understand and agree to contents of informed consent either in writing or verbally.
3. Age 55 or older at the Enrollment Visit.
4. Adults diagnosed with NV-AMD in at least one eye based on the subject's medical record. Fellow eyes diagnosed with dry AMD may be included as secondary eyes to a primary eye diagnosed with NV-AMD.

Note: eyes whit other pathologies including pseudocysts, outer retinal tabulations, pigments epithelial, detachments, hemorrhage, sub retinal hyper reflective material (SHRM), geographic atrophy and sub RPE, hypo reflective areas can be enrolled.
5. Best corrected Visual Acuity of 20/320 or better in eyes that will perform self-imaging.
6. Available and willing to set up a device and conduct self-imaging at their home.

Exclusion Criteria:

1. Anti-VEGF treatment for NV-AMD in the study eye(s) at the screening visit.
2. Any other retinal disease requiring steroidal or anti-VEGF injections.
3. Prior experience with the NVHO device.

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Positive percent agreement [ Time Frame: 1 month following reading center grading completion ]
  • Negative percent agreement [ Time Frame: 1 month following reading center grading completion ]
  • Percentage of subjects who successfully completed the setup of the NVHO device [ Time Frame: 5-10 minutes ]
  • Percentage of subjects who Successful completed NVHO self-imaging [ Time Frame: 2-3 minutes ]

Central Contacts and Locations

Central contacts

Theresa Landry, PhD

18174807964theresa.landry@notalvision.com

Lisa Sorrells, BS

8179056748lisa.sorrells@notalvision.com

Locations

Georgia Retina

Recruiting

Marietta, Georgia, United States, 30060

Contacts

Stephanie Hurst

scampbell@garetina.com

Leslie Marcus

770-218-1888lmarcus@garetina.com

Principal Investigator:

Sri Krishna Mukkamala, MD

Retina Associates of Kentucky

Recruiting

Lexington, Kentucky, United States, 40509

Contacts

Diana Holcomb

859-264-2905dholcomb@retinaky.com

Sean Massey

859-264-2905smassey@retinaky.com

Principal Investigator:

Miguel Busquets, MD

Elman Retina Group, P.A.

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

JoAnn Starr

410-686-3000Starr@elmanretina.com

Principal Investigator:

Michael J. Elman, MD

Ophthalmic Cons. of Boston

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jamie Szczepanski

617-314-2636jszczepanski@eyeboston.com

Sandy Chong

617-314-2627schong@eyeboston.com

Principal Investigator:

Jeffrey Heier, MD

Pepose Vision Institute/Midwest Vision Research Foundation

Recruiting

Chesterfield, Missouri, United States, 63017

Contacts

Roxanne Canter

636-534-5126rcanter@midwestvrf.org

Principal Investigator:

Nancy Holekamp, MD

Wagner Macula & Retina Center

Recruiting

Norfolk, Virginia, United States, 23502

Contacts

Michael Boboc

mboboc@wagnerretina.com

Chris Riebling Riebling

757-390-2433criebling@wagnerretina.com

Principal Investigator:

Alan L. Wagner Wagner, MD

Virginia Eye Institute

Recruiting

Richmond, Virginia, United States, 23230

Contacts

Lea Anderlini

804-287-4250anderlinil@vaeye.com

Principal Investigator:

Byron S. Ladd, MD

More Information

Sponsor

Notal Vision Inc.

Last update posted

Mar 9, 2022

Last verified

Jan, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Notal Vision Inc. on 2022-03-09.