Home Monitoring in eAMD Treatment

Age-related macular degeneration (AMD) constitutes a degenerative disease of the retina, and it is a major cause of retinal disease in the western world and one of the most common causes of central vision impairment, with the advanced form affecting 1-3% of its total population. Patients with AMD have a reduction in quality of life, as several activities of daily routine require functional central visual perception, such as driving and reading. Population aging will lead to a considerable increase in AMD prevalence. Today, late-stage AMD is the leading cause of blindness among the elderly in industrialized countries and affects more than 2.5 million patients in the European Union (EU) resulting in direct annual costs of over 2 billion Euros.

Advanced forms of AMD (intermediate AMD or late AMD) are seen primarily in 2 types, exudative AMD involving the presence of choroidal neovascularization and nonexudative or dry AMD with geographic atrophy.

Vascular endothelial growth factor (VEGF) is a major pathogenic factor in eAMD and is a signalling protein that is known to be involved in the pathophysiology of angiogenesis and increases vascular permeability. Medical treatment of neovascular (or exudative) AMD (eAMD) has improved considerably due to the introduction of vascular endothelial growth factor inhibitors (anti-VEGF), which have significantly altered the prognosis of the disease.

The current gold standard treatment of eAMD is regular intravitreal injections of anti-VEGF, such as Aflibercept, in a treat-and-extend (T\&E) or a fixed regimen. Aflibercept acts as a soluble protein for VEGF receptors inhibiting the predominant signaling pathway responsible for angiogenesis and vascular leakage. Currently, medications like Aflibercept 8 mg are used to treat and manage neovascular age-related macular degeneration, diabetic macular edema, myopic choroidal neovascularization, macular edema associated with retinal vein occlusion, and diabetic retinopathy. However, several patients do not respond adequately to this treatment or suffer a loss of efficacy after multiple administrations. In addition, current treatment with intravitreal anti-VEGF agents is associated with a significant treatment burden and costs for patients, caregivers, and physicians.

With these therapies, longer intervals up to 20 or 24 weeks can be achieved. However, there is a need to have real time information from these patients during such longer intervals, avoiding potential functional and/ or anatomical decline or treatment dropouts. Moreover, it is also pivotal to evaluate potential longer treatment intervals without lower clinical outcomes to reassure the confidence in these longer intervals.

The purpose of home-monitoring is to reduce any delay in the treatment of eAMD. This is through 3 mechanisms:

1. Improved patient literacy: patients being provided with standardised information that helps them to self-care: understanding their disease, treatments and what support services are available, and what the red-flag symptoms are that the patient should be quickly re-presenting to their eye clinic if they encounter. 2. Patient participation in monitoring: remote vision data gathered frequently and viewed by the patient gives them the opportunity for identifying smaller changes at an earlier stage. 3. Clinical teams having access to remote-monitoring vision data: remote vision data gathered frequently and viewed by a specialist gives them the opportunity for identifying smaller changes at an earlier stage, especially with the support of AI-driven algorithms.

Additionally, by helping eAMD patients achieve the best clinical outcomes without the demands of monthly or frequent visits, these new technologies may enhance their quality of life and decrease economic and social burden.

• Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 12. [Time frame: From baseline through month 12.]
• Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 24. [Time frame: From baseline through month 24.]
• Proportion of patients with BCVA ≥69 letters at month 12. [Time frame: From baseline through month 12.]
• Proportion of patients with BCVA ≥69 letters at month 24. [Time frame: From baseline through month 24.]
• Average change in central retinal thickness (CRT) from baseline to month 12. [Time frame: From baseline to month 12.]
• Average change in CRT from baseline to month 24. [Time frame: From baseline to month 24.]
• Proportion of patients without fluid at foveal centre at month 12. [Time frame: Month 12.]
• Proportion of patients without fluid at foveal centre at month 24. [Time frame: Month 24.]
• Total number of visits during the two-year treatment period. [Time frame: From baseline through end of study (24 months).]
• Total number of intravitreal injections during the two-year treatment period. [Time frame: From baseline through end of study (24 months).]
• Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 12. [Time frame: Month 12.]
• Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 24. [Time frame: Month 24.]