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Search / Trial NCT05650047

Home OCT Guided Management Study of Subjects Diagnosed With Neovascular-AMD

Launched by NOTAL VISION INC. · Dec 6, 2022

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Trial Information

Current as of January 14, 2025

Unknown status

Keywords

Amd Self Scanning Home Oct

ClinConnect Summary

The Home OCT Guided Management Study is looking at how a special home imaging device can help manage a condition called neovascular age-related macular degeneration (NV-AMD), which affects vision. This device, called the Notal Vision Home OCT (NVHO), allows patients to take pictures of their eyes at home to monitor any fluid buildup. The goal of the study is to see how this device can guide treatment and reduce the amount of fluid in the eyes of participants.

To be eligible for the trial, participants need to be at least 55 years old, have been diagnosed with NV-AMD in at least one eye, and have started treatment with a specific medicine called anti-VEGF. They must also be able to speak and understand English and be willing to take daily eye images at home. Throughout the study, participants can expect to use the NVHO device regularly and receive support to help them with the imaging process. This study is currently recruiting participants of all genders, so if you or someone you know fits the criteria, it may be an opportunity to help advance care for this condition.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • • 1. Ability to speak and understand English with fluency. 2. Ability to understand and agree to contents of informed consent either in writing or verbally. 3. At least 55 years of age on date of Screening Visit. 4. Diagnosed with NV-AMD in at least one eye and initiation of anti-VEGF treatment in that eye. 5. Visual Acuity of 20/320 or better. 6. Available and willing to conduct daily self-imaging at home for the duration of the trial.
  • Exclusion Criteria:
  • • 1. 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).
  • • 2. Subject's schedule not conducive to completing daily tests at home with the Notal Home OCT device for the duration of the study. -

Trial Officials

Jeff Heier, MD

Principal Investigator

Ophthalmic Consultants of Boston, Boston, MA.

About Notal Vision Inc.

Notal Vision Inc. is a pioneering clinical trial sponsor specializing in the development of innovative diagnostic and monitoring solutions for eye diseases, particularly age-related macular degeneration (AMD). With a strong commitment to advancing ocular health, the company leverages cutting-edge technology and data analytics to enhance patient care and improve clinical outcomes. Notal Vision Inc. collaborates with healthcare professionals and researchers to conduct robust clinical trials that validate its novel approaches, ultimately aiming to transform the landscape of ophthalmology and empower patients through early detection and personalized treatment strategies.

Locations

Florence, South Carolina, United States

Boston, Massachusetts, United States

Saint Louis, Missouri, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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