Home OCT-Guided Treatment versus Treat and Extend for the Management of Neovascular AMD (Protocol AO)
- Sponsor: Jaeb Center for Health Research
- Principal Investigator: Kathleen Schildroth, MD
- Study Coordinator: Kris Dietzman
Study Objective:
To determine if Home OCT-guided treatment results in 1) better visual acuity outcomes and/or 2) fewer number of injections over 104 weeks compared with treat and extend dosing for neovascular age-related macular degeneration.
Study Design:
Subjects will be randomized to one of two groups: intravitreal injections of faricimab on a Treat and Extend schedule or intravitreal injections of faricimab on a home optical coherence tomography-guided treatment schedule.
Inclusion Criteria:
- Age ≥ 50 years
- 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 macular neovascularization (MNV) lesion (i.e., any intraretinal or subretinal fluid on OCT) secondary to age-related macular degeneration
- MNV or sequelae of the MNV (i.e., pigment epithelium detachment, subretinal or sub-RPE hemorrhage, or subretinal, sub-RPE or intraretinal fluid) involving the foveal center
- ≥ 1 intermediate drusen (>63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye
Exclusion Criteria:
- 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
- MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia
Contact Kris Dietzman with questions at (608) 263-9035.
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