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Evaluation of an Electric Stimulator for Medical Use by Personal (LRTPM1) for Visual Function in Early to Intermediate Dry Age-Related Macular Degeneration

2026年7月7日 更新者：Nu Eyne Co., Ltd.

A Multicenter, Randomized, Double-Blind, Sham-Controlled, Parallel-Group Exploratory Clinical Trial Evaluating the Efficacy and Safety of an Electric Stimulator for Medical Use by Personal (LRTPM1) in Improving Visual Function in Patients With Early to Intermediate Dry Age-Related Macular Degeneration

The goal of this clinical trial is to evaluate the efficacy and safety of an electric stimulator for medical use by personal (LRTPM1) in patients with early to intermediate dry age-related macular degeneration.

The main questions this study aims to answer are:

  • Does the investigational device improve visual function, as assessed by best corrected visual acuity and contrast sensitivity?
  • What treatment-emergent adverse events occur during the study?

Participants will:

  • Be randomized to receive either active stimulation or sham stimulation
  • Apply the assigned investigational device at home once daily for 30 minutes over a 12-week treatment period
  • Visit the study site for eye examinations and safety assessments
  • Return for a follow-up visit 4 weeks after the end of treatment

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

This study is a multicenter, randomized, double-blind, sham-controlled, parallel-group exploratory clinical trial designed to evaluate the efficacy and safety of an electric stimulator for medical use by personal (LRTPM1) in patients with early to intermediate dry age-related macular degeneration. Eligible participants will be randomized to receive either active stimulation or sham stimulation and will apply the assigned investigational device at home once daily for 30 minutes over a 12-week treatment period, followed by a 4-week post-treatment follow-up visit. The primary objective is to evaluate changes in visual function, as assessed by best corrected visual acuity measured using the ETDRS visual acuity chart and contrast sensitivity testing. Secondary objectives include evaluating changes in geographic atrophy parameters on fundus autofluorescence, drusen area and volume on optical coherence tomography, and vision-related quality of life as assessed by the NEI VFQ-25. Safety will be evaluated based on treatment-emergent adverse events, vital signs, physical examinations, and ophthalmic examinations throughout the study period.

研究の種類

介入

入学 (推定)

40

段階

  • 適用できない

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

研究連絡先のバックアップ

研究場所

  • 韓国
      • Seoul、韓国、05505
        • Asan Medical Center
        • コンタクト：
          • Yoon Jeon Kim, M.D., Ph.D.
          • 電話番号：+82 02-3010-1670
          • メール：anne215@gmail.com
    • Gyeonggi-do
      • Ansan、Gyeonggi-do、韓国、15355
        • Korea University Ansan Hospital
        • コンタクト：
    • Jongno-gu
      • Seoul、Jongno-gu、韓国、03080
        • Seoul National University Hospital
        • コンタクト：

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

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  1. Participants aged 50 years or older
  2. Participants diagnosed with early or intermediate dry age-related macular degeneration
  3. Participants with best corrected visual acuity measured by the ETDRS visual acuity chart of 20/200 or better and 20/30 or worse
  4. Participants who have voluntarily decided to participate in the study and have provided written informed consent.

Exclusion Criteria:

  1. Participants with atrophy involving the foveal center with a diameter of 175 micrometers or greater in at least one eye, as observed by fundus examination or fundus autofluorescence imaging
  2. Participants with exudative age-related macular degeneration in at least one eye, as observed by fundus examination or optical coherence tomography (OCT)
  3. Participants with a history of intraocular injection therapy or macular laser treatment, including focal laser photocoagulation or photodynamic therapy
  4. Participants with retinal or choroidal diseases other than early or intermediate age-related macular degeneration that may affect the study results, including diabetic retinopathy, retinal artery occlusion, retinal vein occlusion, central serous chorioretinopathy, optic neuritis, or uveitis
  5. Participants who have undergone vitrectomy due to retinal disease, or cataract surgery within 1 month prior to screening
  6. Participants with ocular media opacity or other conditions that, in the investigator's opinion, may make ophthalmic imaging difficult to interpret, including cataract, vitreous opacity, or vitreous hemorrhage
  7. Participants with uncontrolled chronic systemic diseases, including diabetes mellitus or chronic kidney disease, or a history of malignancy, except for cases with no recurrence within the past 5 years and no history of chemotherapy
  8. Participants with autoimmune diseases, including Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or Graves' disease
  9. Participants with severe hearing impairment, sensory abnormalities, or cognitive impairment that may make it difficult to properly perform the study procedures or recognize or report adverse events
  10. Participants who are hypersensitive to orbital nerve stimulation and are unable to receive treatment
  11. Participants with a history of drug or alcohol abuse
  12. Participants diagnosed with psychiatric disorders, including depression, schizophrenia, bipolar disorder, or dementia
  13. Participants who have participated in another clinical trial within 30 days prior to screening
  14. Participants who are considered to have other contraindications to use of the investigational medical device, including underlying cardiac disease, seizure-related disorders, implanted metal or electronic devices in the head or neck area including deep brain stimulators, unexplained pain, implanted or wearable pacemakers, or other conditions listed in the product precautions and contraindications. Dental implants are exempt.
  15. Participants who, in the opinion of the investigator, are deemed inappropriate for participation in the study
  16. Female participants of childbearing potential who do not agree to use medically accepted contraception during the study period. Medically accepted methods of contraception include condoms, oral contraceptives used consistently for at least 3 months, injectable or implantable contraceptives, or intrauterine devices.

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

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Experimental Group (Active Stimulation, n=20)
Participants randomized to the active stimulation group will receive the investigational electric stimulator for medical use by personal (LRTPM1). Participants will apply the assigned device at home once daily for 30 minutes over a 12-week treatment period, followed by a 4-week post-treatment follow-up.
デバイス：Transcutaneous Electrical Stimulation
The active intervention uses transcutaneous electrical stimulation (TES) delivered by the investigational personal-use electric stimulator (LRTPM1). Electrodes are attached to the ocular and periocular area, and the device delivers pulsed electrical stimulation. Participants will apply the assigned device once daily for 30 minutes over a 12-week treatment period.
他の名前：
  • TES
  • 神経刺激
  • 神経調節
  • 電気刺激
偽コンパレータ：Control Group (Sham Stimulation, n=20)
Participants randomized to the sham stimulation group will receive a sham device that is identical in appearance to the investigational device but does not provide active stimulation. Participants will apply the assigned device at home once daily for 30 minutes over a 12-week treatment period, followed by a 4-week post-treatment follow-up.
デバイス：Sham Transcutaneous Electrical Stimulation
The sham device is identical in appearance to the active investigational device but does not provide active electrical stimulation. Participants will apply the assigned sham device once daily for 30 minutes over a 12-week treatment period.
他の名前：
  • シャム

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
Change in Best Corrected Visual Acuity (BCVA) Measured by ETDRS Letter Score
時間枠：Baseline, Week 2, Week 6, Week 12, Week 16
Change from baseline in best corrected visual acuity (BCVA) measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart. BCVA will be recorded as an ETDRS letter score. Higher scores indicate better visual acuity.
Baseline, Week 2, Week 6, Week 12, Week 16
Change in Contrast Sensitivity
時間枠：Baseline, Week 2, Week 6, Week 12, Week 16
Change from baseline in contrast sensitivity as measured using a contrast sensitivity chart at four spatial frequencies (3, 6, 12, and 18 cycles/degree). Contrast sensitivity is recorded as a level value from 1 to 8, with higher recorded values indicating better ability to perceive contrast differences.
Baseline, Week 2, Week 6, Week 12, Week 16

二次結果の測定

結果測定
メジャーの説明
時間枠
Change From Baseline in Geographic Atrophy Maximum Diameter and Area on Fundus Autofluorescence
時間枠：Baseline, Week 2, Week 6, Week 12, Week 16
Change from baseline in the maximum diameter and area of geographic atrophy as assessed by fundus autofluorescence imaging.
Baseline, Week 2, Week 6, Week 12, Week 16
Change From Baseline in Drusen Area and Volume on Optical Coherence Tomography (OCT)
時間枠：Baseline, Week 6, Week 12, Week 16
Change from baseline in drusen area and volume as assessed by optical coherence tomography (OCT).
Baseline, Week 6, Week 12, Week 16
Change From Baseline in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Score
時間枠：Baseline, Week 12
Change from baseline in vision-related quality of life as assessed by the NEI VFQ-25. The total score ranges from 0 to 100, with lower scores indicating better visual function.
Baseline, Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
時間枠：Baseline through Week 16
Incidence and severity of treatment-emergent adverse events (TEAEs) occurring from the first investigational device application through Week 16. TEAEs include, but are not limited to, transient dizziness, drowsiness, skin redness, skin allergy, headache, pain and muscle spasms, ocular symptoms such as transient eye pain, ocular discomfort, and ocular hyperemia, and hypersensitivity reactions around the application site. Safety will be assessed through monitoring of vital signs, physical examinations, ophthalmic examinations, and adverse event reporting throughout the study period.
Baseline through Week 16

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

Nu Eyne Co., Ltd.

捜査官

  • スタディディレクター：Dohyoung Kim、Nu Eyne Co., Ltd.

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 (推定)

2026年7月9日

一次修了 (推定)

2027年12月9日

研究の完了 (推定)

2028年4月17日

試験登録日

最初に提出

2026年7月7日

QC基準を満たした最初の提出物

2026年7月7日

最初の投稿 (実際)

2026年7月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月13日

QC基準を満たした最後の更新が送信されました

2026年7月7日

最終確認日

2026年7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

  • NE_RTN_003
  • 1957 (その他の識別子：Ministry of Food and Drug Safety(MFDS))

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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