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

Launched by JAEB CENTER FOR HEALTH RESEARCH · Jun 6, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different ways to manage a condition called neovascular age-related macular degeneration (AMD), which affects the central part of the retina and can lead to vision loss. The trial is comparing a new approach called Home Optical Coherence Tomography (OCT)-guided treatment with a standard method known as "treat and extend." In the Home OCT method, participants will use a device at home to monitor their eye health daily, which will help doctors decide when to provide treatment.

To participate, individuals need to be at least 50 years old, able to consent to the study, and willing to perform daily monitoring for two years. They should also have a specific type of eye condition that hasn't been treated before, along with certain eye characteristics. Throughout the trial, participants can expect regular check-ins with the research team and support to help them with the home monitoring process. This study aims to find out if the Home OCT method is effective and convenient for managing AMD, which could lead to better outcomes for patients in the future.

Gender

ALL

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-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