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Recruiting Phase 3 NCT05904028

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

Trial Parameters

Condition Neovascular Age-related Macular Degeneration
Sponsor Jaeb Center for Health Research
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 600
Sex ALL
Min Age 50 Years
Max Age N/A
Start Date 2023-11-09
Completion 2027-07-30
Interventions
Intravitreal injections of 6 mg faricimab on a Treat and Extend scheduleIntravitreal injections of 6 mg faricimab on a home optical coherence tomography-guided treatment schedule

Brief Summary

Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.

Eligibility Criteria

Key Inclusion Criteria: * 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 Key Exclusion Criteria for Study Eye: * 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-

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