Home Monitoring in eAMD Treatment (HOME)

Association for Innovation and Biomedical Research on Light and Image

Status: Not yet enrolling

Conditions: Exudative Age-Related Macular Degeneration

Treatments: Drug: Aflibercept 8mg

Study type: Observational

Funder types: Other

Identifiers

NCT07340372

4C-2024-15

Details and patient eligibility

About

The goal of this observational clinical study is to collect more information about the efficacy of Aflibercept 8 mg injections in people with eAMD. The main questions it aims to answer are:

• To reassure patients and doctors with longer intervals using home monitoring app;
• To assess patient reported outcomes (PROMs) and Value-based Healthcare.

Participants already taking Aflibercept 8 mg as part of their regular medical care for eAMD will undergo regular ophthalmological examination and use a home monitoring app, in a one year and a two-year treatment period.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults (≥ 55 years old) with exudative AMD in the study eye.
• Treatment-naïve patients or patients who have started treatment with IVT anti-VEGF (aflibercept 2 mg, aflibercept 8 mg, faricimab, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) up to 48 weeks before inclusion.
• BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 85 to 34 (approximate Snellen equivalent of 20/20 to 20/200) in the study eye with decreased vision determined to be primarily the result of eAMD.
• Willing and able to comply with clinic visits and study-related procedures.
• Provide informed consent signed by study participant or legally acceptable representative.
• Own a working smartphone or tablet compatible with the OKKO Health application.
• Be able to operate the application after training according to OKKO Health indications of use: be alert and mentally competent, has competent dexterity and has normal or corrected hearing to normal audio level.

Exclusion criteria

• Evidence of macular edema due to any cause other than eAMD in either eye.
• Other ocular disease in the study eye that could prevent an accurate evaluation of treatment efficacy like, diabetic macular edema, posterior uveitis, corneal opacity, vein occlusion, macular dystrophy.
• IVT anti-VEGF or steroid implants (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium, triamcinolone, dexamethasone, fluocinolone) for more than 1 year before inclusion.
• Treatment with ocriplasmin (JETREA®) in the study eye at any time.