Home OCT Guided Management Study of Subjects Diagnosed With Neovascular-AMD
1 other identifier
observational
15
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2022
Shorter than P25 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 9, 2022
CompletedFirst Submitted
Initial submission to the registry
December 6, 2022
CompletedFirst Posted
Study publicly available on registry
December 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2023
CompletedMay 22, 2023
December 1, 2022
11 months
December 6, 2022
May 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Area under the fluid volume trajectory between treatments (nl-days) during the study period by fluid type (IRF/SRF/TRF)
6 months
Secondary Outcomes (10)
Percentage of days with successful imaging attempts during daily testing
6 months
Percentage of days with MSI≥2 and with output eligible for fluid quantification
6 months
Dates of injections by type of drug during the study period
6 months
Retina thickness in the central 1 mm circle (CST) and in the entire scan area
6 months
Area under the fluid volume trajectory between treatments (nl-days) during the reference period by fluid type (IRF/SRF/TRF)
6 months
- +5 more secondary outcomes
Eligibility Criteria
The study population will include approximately 15 subjects diagnosed with NV-AMD in at least one eye. Subjects may have previously participated in Notal Home OCT studies. Both eyes of the subjects will be enrolled unless an eye does not meet the inclusion criteria of VA ≥20/320. If the eye that does not meet the inclusion criteria is the only eye with NV-AMD, the subject will not be enrolled.
You may qualify if:
- \. 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. -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Ophthalmic Cons. of Boston
Boston, Massachusetts, 02114, United States
Pepose Vision Institute
St Louis, Missouri, 63017, United States
Palmetto Retina Center
Florence, South Carolina, 29501, United States
Related Publications (1)
Holekamp NM, de Beus AM, Clark WL, Heier JS. PROSPECTIVE TRIAL OF HOME OPTICAL COHERENCE TOMOGRAPHY-GUIDED MANAGEMENT OF TREATMENT EXPERIENCED NEOVASCULAR AGE-RELATED MACULAR DEGENERATION PATIENTS. Retina. 2024 Oct 1;44(10):1714-1731. doi: 10.1097/IAE.0000000000004167. Epub 2024 Sep 12.
PMID: 39287534DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff Heier, MD
Ophthalmic Consultants of Boston, Boston, MA.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2022
First Posted
December 14, 2022
Study Start
September 9, 2022
Primary Completion
July 26, 2023
Study Completion
September 9, 2023
Last Updated
May 22, 2023
Record last verified: 2022-12