Pterygopalatine Ganglion Stimulation for the Treatment of Geographic Atrophy
Feasibility and Safety Evaluation of Pterygopalatine Ganglion Stimulation in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Controlled Pilot Study
The goal of this clinical trial is to evaluate the feasibility and safety of pterygopalatine ganglion (PPG) stimulation in adults with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
The main questions it aims to answer are:
Is PPG stimulation feasible to implement, as reflected by participant adherence to the intervention and completion of follow-up assessments? Is PPG stimulation safe, as assessed by the incidence of adverse events and clinical ophthalmic examinations? What are the preliminary effects of PPG stimulation on choroidal perfusion, retinal sensitivity, visual acuity, and the progression of GA lesion area?
Researchers will compare active PPG stimulation with sham stimulation (a procedure that mimics the intervention without delivering real stimulation) to assess feasibility and safety, while exploring potential therapeutic effects.
Participants will:
Receive active or sham PPG stimulation according to randomization over a 12-month study period Attend scheduled clinic visits for safety monitoring and multimodal ophthalmic assessments Undergo examinations including optical coherence tomography (OCT), fundus autofluorescence imaging, microperimetry, and visual acuity testing
調査の概要
状態
条件
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Xiehe Kong, MD
- 電話番号：021-13621775647
- メール：ynomrahkong@163.com
研究場所
-
-
-
Shanghai、中国、200030
- Shanghai Research Institute of Acupuncture and Meridian
-
コンタクト：
- Xiehe Kong, MD
- 電話番号：021-13621775647
- メール：ynomrahkong@163.com
-
-
参加基準
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
説明
Inclusion Criteria:
- Best-corrected visual acuity (BCVA), as measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, ranging from 25 to 80 letters (Snellen equivalent, 20/320 to 20/25).
A confirmed diagnosis of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), with no involvement of the foveal center. Fundus autofluorescence (FAF) imaging must demonstrate a total GA area of 2.5 to 17.5 mm² located within a 30° field centered on the fovea, with the presence of any pattern of increased autofluorescence at the junctional zone of GA. In cases of multifocal GA, at least one lesion must be ≥1.25 mm² in size.
- If both eyes meet the eligibility criteria, the eye with the worse BCVA will be selected as the study eye. If BCVA is equal in both eyes, the right eye will be designated as the study eye.
Exclusion Criteria:
- History or evidence of submacular surgery or other treatments for AMD in the study eye, with the exception of oral vitamin and mineral supplementation.
- History of intraocular surgery within 3 months prior to screening, or the presence of ocular conditions requiring surgical intervention during the study period.
- Receipt of any periocular or intravitreal injection therapy in the study eye within 3 months prior to screening.
- History or evidence of choroidal neovascularization in either eye, or the presence of any other retinal disease that may confound the assessment of macular structure or function (e.g., diabetic retinopathy or pathologic myopia).
- Presence of severe systemic disease or any other condition deemed unsuitable for study participation.
- Inability to comply with scheduled visits or complete study procedures due to cognitive impairment or other factors, as judged by the investigator.
研究計画
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
偽コンパレータ：シャム刺激
|
During sham stimulation, a disposable stainless steel needle (0.25 × 25 mm) was inserted superficially at the same anatomical location as in the active stimulation group, to a depth of approximately 2 cm.
Ultrasound guidance was applied in an identical manner to that used in the active intervention to mimic the procedural experience.
However, the internal circuitry of the stimulation device was disconnected to prevent current delivery.
The device interface continued to display real-time parameters, including current intensity, frequency, and stimulation duration, thereby maintaining the appearance of active operation.
他の名前：
|
|
実験的：積極的な刺激
|
Electrical stimulation was delivered using a disposable sterile needle electrode (0.30 × 60 mm; Beijing Keyuan Medical Devices Co., Ltd., China).
Under ultrasound guidance, the needle tip was advanced into the pterygopalatine fossa.
Ipsilateral pterygopalatine ganglion stimulation was administered to the study eye using an intermittent waveform at a frequency of 5 Hz and a current intensity of 1-2 mA for 10 minutes.
The stimulation intensity was adjusted to elicit a mild local electrical sensation as perceived by the participant.
他の名前：
|
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 |
|---|---|---|
|
Proportion of participants who completed the trial
時間枠：At 12 months
|
Proportion of participants who were successfully randomized to either intervention group, fully adhered to the assigned intervention protocol, and completed all scheduled follow-up assessments.
|
At 12 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Incidence of adverse events
時間枠：From enrollment to 12 months
|
From enrollment to 12 months
|
|
|
Choroidal structure
時間枠：-7 to 0 days, 1, 3, 6, 9, and 12 months
|
-7 to 0 days, 1, 3, 6, 9, and 12 months
|
|
|
Retinal sensitivity
時間枠：Baseline (0), 6 months, and 12 months
|
Baseline (0), 6 months, and 12 months
|
|
|
Standard and low-luminance best corrected visual acuity
時間枠：-7 to 0 days, 1, 3, 6, 9, and 12 months
|
-7 to 0 days, 1, 3, 6, 9, and 12 months
|
|
|
Geographic atrophy lesion area and square root-transformed geographic atrophy area
時間枠：-7 to 0 days, 6 months, and 12 months
|
-7 to 0 days, 6 months, and 12 months
|
|
|
Contrast sensitivity
時間枠：Baseline (0), 1, 3, 6, 9, and 12 months
|
Baseline (0), 1, 3, 6, 9, and 12 months
|
|
|
25-item National Eye Institute Visual Function Questionnaire score
時間枠：Baseline (0), 6 months, and 12 months
|
Vision-related quality of life was assessed using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
This corresponds to a score between 0 and 100, with higher scores indicating better visual quality of life
|
Baseline (0), 6 months, and 12 months
|
|
Treatment credibility scale score
時間枠：1 week and 12 months
|
Assessed by asking participants to rate their response to five questions on a 10-point treatment credibility scale developed by Borkovec and Nau.
Higher scores represent higher expectations of efficacy.
|
1 week and 12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
Pterygopalatine ganglion stimulationの臨床試験
-
Biotronik SE & Co. KG完了
-
Biotronik SE & Co. KG完了心臓ペーシング、人工ドイツ, イスラエル, 香港, オーストリア, チェコ共和国, オーストラリア, ブラジル, カナダ, スロバキア, スペイン
-
Tanta University完了超音波 | 機能的内視鏡下副鼻腔手術 | 蝶口蓋神経節ブロック | BrainLabナビゲーションエジプト