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

• Status: Not yet recruiting
• Trial end date: 2027-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jaeb Center for Health Research
• Collaborators: Juvenile Diabetes Research Foundation; National Eye Institute (NEI); National Institutes of Health (NIH)
• Treatments: Faricimab

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 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

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-VEGF or anti-VEGF/anti-Ang2 agent or with macular laser for any indication

• Treatment with intravitreal corticosteroids within the last 6 months

• Any condition that may preclude adequate imaging of the macula (e.g., dense cataract or other media opacity, severe ptosis)

• MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia