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eAMD治療におけるホームモニタリング (HOME)

2026年11月11日 更新者：Association for Innovation and Biomedical Research on Light and Image

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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

観察的

入学 (推定)

80

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前：Joana F Tavares, PhD
  • 電話番号：+351 239 480137
  • メール：home@aibili.pt

研究場所

  • ポルトガル
      • Coimbra、ポルトガル
        • 募集
        • Espaço Médico de Coimbra, Lda.
        • コンタクト：
          • João Figueira
      • Coimbra、ポルトガル
        • 募集
        • Unidade Local de Saúde de Coimbra, E.P.E.
        • コンタクト：
          • Cláudia Farinha
      • Leiria、ポルトガル
        • 募集
        • Unidade Local de Saúde de Leiria, E.P.E.
        • コンタクト：
          • Nuno Oliveira
      • Lisbon、ポルトガル
        • 募集
        • Instituto Português de Microcirurgia Ocular, Lda.
        • コンタクト：
          • José Roque
      • Lisbon、ポルトガル
        • まだ募集していません
        • Unidade Local de Saúde de Lisboa Ocidental - Hospital de Egas Moniz
        • コンタクト：
          • Maria Picoto
      • Loures、ポルトガル
        • 募集
        • Unidade Local de Saúde Loures-Odivelas
        • コンタクト：
          • Belmira Beltrán
      • Porto、ポルトガル
        • まだ募集していません
        • Unidade Local de Saúde de Santo António, E.P.E.
        • コンタクト：
          • Miguel Lume
      • Porto、ポルトガル
        • 一時停止
        • Unidade Local de Saúde de São João, E.P.E.

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

55年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

Patients with eAMD with a diagnosis or under treatment for a period ≤ 1year.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 観測モデル：COHORT
  • 時間の展望：PROSPECTIVE

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Average change in best corrected visual acuity (BCVA) from baseline to month 12.
時間枠：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.
From baseline and then at each of the subsequent visits until month 12.
Average change in BCVA from baseline to month 24.
時間枠：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.
From baseline and then at each of the subsequent visits until month 24.

二次結果の測定

結果測定
メジャーの説明
時間枠
Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 12.
時間枠：From baseline through 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.

The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
From baseline through month 12.
Proportion of patients gaining ≥5, ≥10, ≥15 letters in BCVA at month 24.
時間枠：From baseline through 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.

The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
From baseline through month 24.
Proportion of patients with BCVA ≥69 letters at month 12.
時間枠：From baseline through 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.

The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
From baseline through month 12.
Proportion of patients with BCVA ≥69 letters at month 24.
時間枠：From baseline through 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.

The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity.
From baseline through month 24.
Average change in central retinal thickness (CRT) from baseline to month 12.
時間枠：From baseline to month 12.

Central retinal thickness refers to the measurement of the retinal tissue thickness in the central region of the retina, assessed using Optical Coherence Tomography (OCT).
From baseline to month 12.
Average change in CRT from baseline to month 24.
時間枠：From baseline to month 24.

Central retinal thickness refers to the measurement of the retinal tissue thickness in the central region of the retina, assessed using OCT.
From baseline to month 24.
Proportion of patients without fluid at foveal centre at month 12.
時間枠：Month 12.

Fluid at foveal centre is measured using OCT.
Month 12.
Proportion of patients without fluid at foveal centre at month 24.
時間枠：Month 24.

Fluid at foveal centre is measured using OCT.
Month 24.
Total number of visits during the two-year treatment period.
時間枠：From baseline through end of study (24 months).

Count of the number of visits each participant performed 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.
時間枠：From baseline through end of study (24 months).

Count of the intravitreal injections each participant received 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.
時間枠：Month 12.

Proportions are based on the number of participants who have not discontinued the study at the end of the study. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit.
Month 12.
Proportion of patients with ≥ 12, ≥ 16, ≥20 weeks interval at month 24.
時間枠：Month 24.

Proportions are based on the number of participants who have not discontinued the study at the end of the study. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit.
Month 24.
Proportion of accurate alert flags of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts.
時間枠：From baseline to the end of the study.

Accurate alert flags are measured as similar change in clinical status 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.
時間枠：From baseline to the end of the study.

Inaccurate alert flags are measured as no correlation change in clinical status found of the OKKO-identified alerts/patient-driven alerts/clinic-identified alerts.
From baseline to the end of the study.
Adherence to the home monitoring.
時間枠：From baseline to the end of the study.

Adherence determined by patients who use the application to home-monitor VA and metamorphopsia at least weekly and have no more than 2 breaks of 3 weeks in a year.
From baseline to the end of the study.
Costs assigned to National Health System at month 12.
時間枠：Month 12.

Costs assigned to National Health System are estimated through eCRF information such as number of visits, serious adverse events (SAEs) and hospitalizations.
Month 12.
Costs assigned to National Health System at month 24.
時間枠：Month 24.

Costs assigned to National Health System are estimated through eCRF information such as number of visits, SAEs and hospitalizations.
Month 24.
Societal costs at month 12.
時間枠：Month 12.

Societal costs are assessed using a Value-based Healthcare Questionnaire, to be filled by participant and accompaniments.
Month 12.
Societal costs at month 24.
時間枠：Month 24.

Societal costs are assessed using a Value-based Healthcare Questionnaire, to be filled by participant and accompaniments.
Month 24.
Average change in National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) from baseline to month 12.
時間枠：From baseline to month 12.

NEI-VFQ-25 is a validated questionnaire used to assess vision-specific health-related quality of life. All items are scored so that a higher score represents better functioning and each item is converted to a 0 to 100 scale.
From baseline to month 12.
Average change in EQ-5D five-level (EQ-5D-5L) descriptive system from baseline to month 12.
時間枠：From baseline to month 12.

EQ-5D-5L is a validated questionnaire used to measure patient-reported health status and utility values. The questionnaire creates a 5-digit code from five health dimensions, scored as five levels, and the higher score represents worse outcome. The EQ-5D-5L also includes the EuroQol Visual Analogue Scale (EQ-VAS) on a 0 to 100 scale for self-rated health, which higher score means better outcome.
From baseline to month 12.
Average change in National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) from baseline to month 24.
時間枠：From baseline to month 24.

NEI-VFQ-25 is a validated questionnaire used to assess vision-specific health-related quality of life. All items are scored so that a higher score represents better functioning and each item is converted to a 0 to 100 scale.
From baseline to month 24.
Average change in EQ-5D five-level (EQ-5D-5L) descriptive system from baseline to month 24.
時間枠：From baseline to month 24.

EQ-5D-5L is a validated questionnaire used to measure patient-reported health status and utility values. The questionnaire creates a 5-digit code from five health dimensions, scored as five levels, and the higher score represents worse outcome. The EQ-5D-5L also includes the EuroQol Visual Analogue Scale (EQ-VAS) on a 0 to 100 scale for self-rated health, which higher score means better outcome.
From baseline to month 24.
System usability scale (SUS) score.
時間枠：Month 12.

To evaluate user satisfaction and perceived usability of the system at month 12. The SUS uses a 0 to 5 scale for each sentence, which higher scores indicate better outcomes.
Month 12.
Net promoter score (NPS).
時間枠：Month 12.

To evaluate user satisfaction and perceived usability of the system at month 12. The NPS uses a 0 to 10 scale, which higher score indicates better outcome.
Month 12.
Frequency of adverse events (AEs) at month 12.
時間枠：From baseline to month 12.

To evaluate the safety associated with the inclusion of a home monitoring app in the eAMD patient pathway with respect to AEs.
From baseline to month 12.
Frequency of SAEs at month 12.
時間枠：From baseline to month 12.

To evaluate the safety associated with the inclusion of a home monitoring app in the eAMD patient pathway with respect SAEs.
From baseline to month 12.
Frequency of AEs at month 24.
時間枠：From baseline to month 24.

To evaluate the safety associated with the inclusion of a home monitoring app in the eAMD patient pathway with respect to AEs.
From baseline to month 24.
Frequency of SAEs at month 24.
時間枠：From baseline to month 24.

To evaluate the safety associated with the inclusion of a home monitoring app in the eAMD patient pathway with respect to SAEs.
From baseline to month 24.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Association for Innovation and Biomedical Research on Light and Image

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年11月4日

一次修了 (推定)

2028年11月1日

研究の完了 (推定)

2028年11月1日

試験登録日

最初に提出

2026年1月6日

QC基準を満たした最初の提出物

2026年1月6日

最初の投稿 (実際)

2026年1月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月12日

QC基準を満たした最後の更新が送信されました

2026年11月11日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 4C-2024-15

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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