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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
DrugIntravitreal 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
DeviceIntravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Treat and ExtendExperimental treatment 1 intervention
Group B: Home optical coherence tomography-Guided TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
E-ETDRS Change in Visual Acuity Letter Score
Best-corrected visual acuity following protocol-defined refraction. Visual Acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) visual acuity test on a scale from 100 letters (Snellen equivalent of 20/10) to 0 letters (Snellen equivalent of \<20/800). Higher scores indicate better visual acuity, and lower scores indicate worse visual acuity.
Time frame
Baseline to 104 weeks2
Number of intravitreal injections of Faricimab (6.0 mg) in the study eye
Time frame
Baseline to 104 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
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