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 groupsSponsors 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