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

Protocol AO

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

2023-11-09

2027-07-30

2027-07-30

Recruiting

Early phase I

600

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': "Visual acuity and imaging technicians will be masked to the participant's treatment group assignment, as will the central Reading Centers. Investigators, coordinators, and participants will be unmasked to treatment group assignment.", 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

2024-06-05