RecruitingPhase 3NCT05904028
Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD
Sponsor
Jaeb Center for Health Research
Enrollment
600 participants
Start Date
Nov 9, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.
Eligibility
Min Age: 50 Years
Inclusion Criteria7
- 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)
- Best corrected E-ETDRS visual acuity ≥24 ETDRS letters (approximately 20/320 or better (Snellen))
- Previously untreated, active MNV lesion (i.e., any intraretinal or subretinal fluid within the center 3 mm diameter circle on OCT) secondary to age-related macular degeneration
- ≥ 1 intermediate drusen (≥ 63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye
Exclusion Criteria5
- 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)
- MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia
Interventions
DRUGIntravitreal injections of 6 mg faricimab on a Treat and Extend schedule
Intravitreal injections of 6 mg faricimab on a Treat and Extend schedule
DEVICEIntravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule
Intravitreal injections of 6 mg faricimab on a Home OCT-guided treatment schedule
Locations(64)
View Full Details on ClinicalTrials.gov
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NCT05904028