Home OCT Guided Management Study of Subjects Diagnosed With Neovascular-AMD
Status unconfirmed
Conditions studied: Retinal Neovascularization
In brief
During the last 25 years, OCT has become one of the most common imaging technologies used to diagnose and monitor retinal diseases, including AMD. The OCT self-imaging capabilities of the Notal Vision Home OCT (NVHO) system for retinal fluid visualization in the central 10 degrees were validated during several prospective clinical studies1,2,3,4,5. This study is designed to evaluate the retinal fluid exposure of eyes with NV-AMD, using the NVHO system to guide therapy.
Key facts
- Study ID
- NCT05650047
- Run by
- Notal Vision Inc.
- People needed
- 15
- Starts
- 2022-09-09
- Expected to finish
- 2023-09-09
- Last updated by the study team
- 2023-05-22
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
- Subject's schedule not conducive to completing daily tests at home with the Notal Home OCT device for the duration of the study. -
Where it is running
- Ophthalmic Cons. of Boston — Boston, Massachusetts, United States (enrolling)
- Pepose Vision Institute — St Louis, Missouri, United States (enrolling)
- Palmetto Retina Center — Florence, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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