Daily Testing at Home by NV-AMD Subjects With Notal Home OCT.

NCT04650672 | Completed DMC

• 1 other identifier: C2020.004
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the ability of subjects with NV-AMD to perform sequential daily self-imaging of their eyes with the self-operated Notal Home OCT device in their homes for 90 days without on-site supervision. The study will include up to 15 subjects.

Conditions

Retinal Neovascularization

Keywords

AMD self-scanning Home-OCT

Outcome Measures

Primary Outcomes (1)

• Percentage of successful imaging attempts during daily testing.

  90 days

Secondary Outcomes (3)

• Percentage of eyes successfully completed the set up and calibration

  10-15 minutes

• Percentage of volume scans with Manufacturer Image quality Index (MSI) >=2 (in a scale of 0-7, where 2 is a pre-defined acceptable-MSI cutoff)

  90 days

• Percentage of eligible B-scans out of the maximum 88 in each volume scan during daily testing

  90 days

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include approximately fifteen (15) subjects diagnosed with NV-AMD in at least one eye with initiation of anti-VEGF treatment within the past 6 months, at treatment intervals 8 weeks or less, in the NV-AMD eye. At least 50% of the subjects in each of the two study sites with active NV-AMD at time of enrollment in at least one eye, defined as presence of intra- and/or subretinal fluid as seen on the office OCT. Approximately 50% of the eyes with fluid will have intra retinal fluid and at approximately 50% will have sub retinal fluid. Eyes may have both types of fluid.

You may qualify if:

• Ability to speak and understand English with fluency.
• Ability to understand and agree to contents of informed consent either in writing or verbally.
• At least 55 years of age on date of Screening Visit.
• Diagnosed with NV-AMD in at least one eye and initiation of anti-VEGF treatment in that eye.
• At least one enrolled eye per subject had retinal fluid treated with anti-VEGF in the prior 6 months, with a treatment interval of 8 weeks or less.
• Visual Acuity of 20/320 or better.
• 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.

Sponsors & Collaborators

• Notal Vision Inc.: lead

Study Sites (2)

Ophthalmic Cons. of Boston

Boston, Massachusetts, 02114, United States

Location

Pepose Vision Institute

St Louis, Missouri, 63017, United States

Location

MeSH Terms

Conditions

Retinal Neovascularization

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeff Heier, MD

  Ophthalmic Consultants of Boston, Boston, MA.

  PRINCIPAL INVESTIGATOR

• Nancy Holekamp, MD

  Pepose Vision Institute, Chesterfield, MO.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: December 8, 2020
• Primary Completion: August 4, 2021
• Study Completion: September 30, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

US (2)