Retinal Neovascularization Clinical Trial
Official title:
Home OCT Guided Management Study of Subjects Diagnosed With Neovascular-AMD
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.
Status | Recruiting |
Enrollment | 15 |
Est. completion date | September 9, 2023 |
Est. primary completion date | July 26, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years and older |
Eligibility | 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. - |
Country | Name | City | State |
---|---|---|---|
United States | Ophthalmic Cons. of Boston | Boston | Massachusetts |
United States | Palmetto Retina Center | Florence | South Carolina |
United States | Pepose Vision Institute | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Notal Vision Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the fluid volume trajectory between treatments (nl-days) during the study period by fluid type (IRF/SRF/TRF) | 6 months | ||
Secondary | Percentage of days with successful imaging attempts during daily testing | 6 months | ||
Secondary | Percentage of days with MSI=2 and with output eligible for fluid quantification | 6 months | ||
Secondary | Dates of injections by type of drug during the study period | 6 months | ||
Secondary | Retina thickness in the central 1 mm circle (CST) and in the entire scan area | 6 months | ||
Secondary | Area under the fluid volume trajectory between treatments (nl-days) during the reference period by fluid type (IRF/SRF/TRF) | 6 months | ||
Secondary | Maximal fluid volume reached averaged in a moving window of 3 consecutive testing days during the study period by fluid type (IRF/SRF/TRF) | 6 months | ||
Secondary | Characteristics of dry AMD (iAMD) eyes converted to NV-AMD and identified with the NVHO, including visual acuity and fluid volume. | 6 months | ||
Secondary | Time spent by physicians and staff in review of NVHO report and updating the patient's electronic medical record | 6 months | ||
Secondary | Time spent by physician and staff to communicate with the patients upon enrolment and during scheduling of NVHO related office visits | 6 months | ||
Secondary | Visual acuity during office visits | 6 months |
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