Home Monitoring in eAMD Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- Average change in best corrected visual acuity (BCVA) from baseline to month 12.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Average change in best corrected visual acuity (BCVA) from baseline to month 12.
时间窗: From baseline and then at each of the subsequent visits until month 12.
BCVA will be assessed on both eyes, using best correction determined from protocol refraction. Measurements will be taken in a sitting position using ETDRS-like visual acuity testing charts at a starting distance of 4 meters.
Average change in BCVA from baseline to month 24.
时间窗: From baseline and then at each of the subsequent visits until month 24.
BCVA will be assessed on both eyes, using best correction determined from protocol refraction. Measurements will be taken in a sitting position using ETDRS-like visual acuity testing charts at a starting distance of 4 meters.
次要结局
- Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 12.(From baseline through month 12.)
- Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 24.(From baseline through month 24.)
- Proportion of patients with BCVA ≥69 letters at month 12.(From baseline through month 12.)
- Proportion of patients with BCVA ≥69 letters at month 24.(From baseline through month 24.)
- Average change in central retinal thickness (CRT) from baseline to month 12.(From baseline to month 12.)
- Average change in CRT from baseline to month 24.(From baseline to month 24.)
- Proportion of patients without fluid at foveal centre at month 12.(Month 12.)
- Proportion of patients without fluid at foveal centre at month 24.(Month 24.)
- Total number of visits during the two-year treatment period.(From baseline through end of study (24 months).)
- Total number of intravitreal injections during the two-year treatment period.(From baseline through end of study (24 months).)
- Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 12.(Month 12.)
- Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 24.(Month 24.)
- Proportion of accurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts.(From baseline to the end of the study.)
- Proportion of inaccurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts.(From baseline to the end of the study.)
- Adherence to the home monitoring.(From baseline to the end of the study.)
- Costs assigned to National Health System at month 12.(Month 12.)
- Costs assigned to National Health System at month 24.(Month 24.)
- Societal costs at month 12.(Month 12.)
- Societal costs at month 24.(Month 24.)
- Average change in National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) from baseline to month 12.(From baseline to month 12.)
- Average change in EQ-5D five-level (EQ-5D-5L) descriptive system from baseline to month 12.(From baseline to month 12.)
- Average change in National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) from baseline to month 24.(From baseline to month 24.)
- Average change in EQ-5D five-level (EQ-5D-5L) descriptive system from baseline to month 24.(From baseline to month 24.)
- System usability scale (SUS) score.(Month 12.)
- Net promoter score (NPS).(Month 12.)
- Frequency of adverse events (AEs) at month 12.(From baseline to month 12.)
- Frequency of SAEs at month 12.(From baseline to month 12.)
- Frequency of AEs at month 24.(From baseline to month 24.)
- Frequency of SAEs at month 24.(From baseline to month 24.)