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治験 NCT07409389（対象：AMD - Age-Related Macular Degeneration）は募集準備中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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香港理工大学Repeated Low-Level Red-Light Therapy in Dry Age-Related Macular Degeneration 94 非侵襲 自宅 無作為化 二重盲検
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07409389 は 介入研究 臨床試験 で、AMD - Age-Related Macular Degeneration に関するものです。現在は 募集準備中 で、2026年1月26日 に開始予定です。94 名の参加者 の募集が計画されています。この試験は 香港理工大学 によって主導され、2026年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月13日 です。
概要
This prospective, double-blind, randomized controlled trial aims to evaluate the efficacy and safety of repeated low-level red-light (RLRL) therapy in patients with dry age-related macular degeneration (AMD). The primary objective is to assess the effect of RLRL therapy on visual function in patients with dry AMD, while the secondary objective is to evaluate its safety and tolerability.
Seventy-four participants age...
もっと見る公式タイトル
Safety and Efficacy of Repeated Low-Level Red-Light Therapy in Dry Age-Related Macular Degeneration: A Randomized Controlled Trial
疾患名
AMD - Age-Related Macular Degenerationその他の研究識別子
- HSEARS20250917007
NCT番号
開始日
2026-01-26
最終更新日
2026-02-13
終了予定日
2026-12-01
目標参加者数
94
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集準備中
キーワード
Dry Age-Related Macular Degeneration
Red light therapy
Visual function
Red light therapy
Visual function
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
四重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実薬対照薬RLRL therapy group The RLRL therapy group will undergorepeated low-level red-light therapy (RLRL).The light power through a 4-mm pupil is 0.29 mW for the RLRL device. | RLRL device Each participant in the RLRL therapy group will be provided a repeated low-level red-light therapy (RLRL) device, which they are required to use twice daily for 3minutes per session, with a minimum interval of 4 hours between sessions (5 days a week) for three month. |
シャム対照薬Sham therapy group The sham therapy group will use a sham device, which operates at only 10% of the active RLRL device's power. The light power through a 4-mm pupil is 0.03mW for the sham device. | Sham device Each participant in the sham group will be provided a sham therapy device, which they are required to use twice daily for 3minutes per session, with a minimum interval of 4 hours between sessions (5 days a week) for three month. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
The mean change in BCVA measured by ETDRS chart | An Early Treatment Diabetic Retinopathy Study (ETDRS) chart (Precision Vision, Villa Park, Illinois, USA) with standard illumination will be used to measure distance visual acuity. Best corrected visual acuity and uncorrected visual acuity will be measured. | At 1month and 3 months compared to baseline |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Change in central drusen volume measured by optical coherence tomography (OCT) | Spectral-domain OCT (Spectralis OCT; Heidelberg Engineering, Heidelberg, Germany) with 49 parallel B-scan lines will be used to image the study eye. The automated real-time (ART) function will average 16 frames per scan. Measurements will include sub-RPE macular drusen volume within the 6 × 6 mm ETDRS grid and mean central subfield sub-RPE drusen thickness within the central 1-mm ETDRS subfield. Automated and manually corrected segmentation of Bruch's membrane and the RPE, provided by the Heidelberg software, will be used for analysis. | At 1month and 3 months compared to baseline |
Change in central drusen thickness measured by optical coherence tomography (OCT). | Spectral-domain OCT (Spectralis OCT; Heidelberg Engineering, Heidelberg, Germany) with 49 parallel B-scan lines will be used to image the study eye. The automated real-time (ART) function will average 16 frames per scan. Measurements will include sub-RPE macular drusen volume within the 6 × 6 mm ETDRS grid and mean central subfield sub-RPE drusen thickness within the central 1-mm ETDRS subfield. Automated and manually corrected segmentation of Bruch's membrane and the RPE, provided by the Heidelberg software, will be used for analysis. | At 1month and 3 months compared to baseline |
Change in retinal sensitivity using microperimetry. | Retinal sensitivity will be assessed using microperimetry performed with the MP-3 microperimeter (NIDEK Co., Ltd., Gamagori, Japan). The device will be used to measure localized retinal sensitivity across the macular region following a standardized testing protocol. Retinal sensitivity thresholds and fixation stability parameters will be recorded and analyzed according to the manufacturer's recommendations. | At 1month and 3 months compared to baseline |
Outcomes of visual-related quality of life (VRQL) assessed by the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) | The 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) will be administered to assess VRQL. This instrument covers 12 subscales: general health, general vision, ocular pain, near vision, distance vision, social functioning, role limitations, mental health, dependency, driving, color vision, and peripheral vision. Each subscale score ranges from 0 to 100, with higher scores indicating better self-reported visual function. | At 3 months compared to baseline |
Size of GA assessed by fundus autofluorescence (FAF) imaging | FAF will be acquired using 488-nm excitation (Spectralis OCT; Heidelberg Engineering, Heidelberg, Germany). GA lesions will be quantified with Region Finder software (Heidelberg Engineering), which provides semi-automated measurement of areas with homogeneous hypoautofluorescence and enables longitudinal assessment of lesion growth. | At 1month and 3 months compared to baseline |
Change in contrast sensitivity using the Mars Letter Contrast Sensitivity Test | The Mars Letter Contrast Sensitivity Test (Mars Perceptrix, Chappaqua, NY, USA) will be performed under standardized photopic lighting at 50 cm. Participants will read letters sequentially from highest to lowest contrast, with contrast decreasing in 0.04 log unit steps. Testing will continue until two consecutive errors are made. Final scores will be calculated per manufacturer's guidelines and expressed in log contrast sensitivity units. | At 1month and 3 months compared to baseline |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
50 Years
対象性別
全て
Age ≥ 50 years old.
Diagnosis of dry AMD in Age-Related Eye Disease Study (AREDS) category 2 to 4, as determined by color fundus photography and fundus autofluorescence imaging. The AREDS categories will be defined as follows:
i) AREDS category 2 (early AMD): Multiple small drusen, a few intermediate drusen (63-124 μm in diameter), or retinal pigment epithelium (RPE) abnormalities ii) AREDS category 3 (intermediate AMD): Extensive intermediate drusen, including at least one large drusen (> 125 μm in diameter), or geographic atrophy (GA) not involving the center of the fovea.
iii) AREDS category 4 (advanced/late AMD): GA involving the center of the macula.
If both eyes meet the inclusion criteria, both eyes will be included in the study analysis.
ETDRS BCVA score between 50 and 75 (Snellen equivalent of 20/32 to 20/100). Willingness to provide written informed consent after being informed of the nature of the study.
- Previous or active neovascular maculopathy.
- Presence of center involving GA within the central 500 μm of the ETDRS grid.
- Ocular disease other than dry AMD that could cause drusen (glomerulonephritis Type 2, Autosomal dominant drusen), GA (North Carolina macular dystrophy), or mitochondrial disorders (parafoveal petaloid GA, Stargardt disease).
- Invasive eye surgery (e.g. cataract extraction, capsulotomy) within 3 months.
- Cognitive impairment or history of epilepsy.
- Other significant ocular disease affecting visual acuity (e.g., diabetic macular edema, uncontrolled glaucoma, active uveitis, vitreoretinal disease, intraocular tumor, retinal vascular disease, lens opacities more severe than C2, N2, P2 \[LOCS III\]).
Afterimage > 5 min (contraindication of red-light therapy).
香港理工大学212 件のアクティブな治験を探索試験中央連絡先
連絡先: Mingguang He, 85234002795, [email protected]
連絡先: Yanxian Chen, 85227666111, [email protected]
1 1カ国の場所
Hong Kong
The Hong Kong Polytchnic University, Hong Kong, Hong Kong, China
Staff, 連絡先, 85227665111, [email protected]