Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorJaeb Center for Health Research
About this trial
Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.
Eligibility criteria
Qualifiers
Age ≥ 50 years
Have the capacity to consent on his/her own behalf
Able to successfully and independently complete at least one self-scanning session on the Home OCT device located at the enrolling clinical site
Willing to perform once daily Home OCT monitoring tests for 2 years without significant interruption (such as travel of more than 14 days)
Disqualifiers
Previous treatment for MNV (intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent, or any other AMD therapy)
Prior treatment with intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent or with macular laser for any indication
Treatment with intravitreal corticosteroids within the last 6 months
A condition that, in the opinion of the investigator, would preclude participation in the study or ability to complete daily Home OCT scans for 2 years (e.g., unstable medical status that may preclude successful completion of follow-up, dementia, Alzheimer's disease, uncontrollable tremors)
Trial design
Treatments tested in this trial
- Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
- Intravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule
Treatment groups
600 Participants
are divided into 2 treatment groupsLocations
65Canada
Chow Berger Koushan Medicine Professional Corporation o/a Toronto Retina InstituteM3C0G9, North YORKOntario, Canada
University Health NetworkM5T 2S8, TorontoOntario, Canada
United States
California
Kent W. Small, MD, AMC91203-1971, Glendale United States
Loma Linda University92354, Loma Linda United States
Sponsors and collaborators
Jaeb Center for Health Research
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Eye Institute (NEI)
Collaborator
Juvenile Diabetes Research Foundation
Collaborator
Source ClinicalTrials.gov