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
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Xiehe Kong, MD
- 电话号码：021-13621775647
- 邮箱：ynomrahkong@163.com
学习地点
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Shanghai、中国、200030
- Shanghai Research Institute of Acupuncture and Meridian
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接触：
- Xiehe Kong, MD
- 电话号码：021-13621775647
- 邮箱：ynomrahkong@163.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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假比较器：假刺激
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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.
其他名称：
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实验性的：主动刺激
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Proportion of participants who completed the trial
大体时间：At 12 months
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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.
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At 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Incidence of adverse events
大体时间：From enrollment to 12 months
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From enrollment to 12 months
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Choroidal structure
大体时间：-7 to 0 days, 1, 3, 6, 9, and 12 months
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-7 to 0 days, 1, 3, 6, 9, and 12 months
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Retinal sensitivity
大体时间：Baseline (0), 6 months, and 12 months
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Baseline (0), 6 months, and 12 months
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Standard and low-luminance best corrected visual acuity
大体时间：-7 to 0 days, 1, 3, 6, 9, and 12 months
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-7 to 0 days, 1, 3, 6, 9, and 12 months
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Geographic atrophy lesion area and square root-transformed geographic atrophy area
大体时间：-7 to 0 days, 6 months, and 12 months
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-7 to 0 days, 6 months, and 12 months
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Contrast sensitivity
大体时间：Baseline (0), 1, 3, 6, 9, and 12 months
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Baseline (0), 1, 3, 6, 9, and 12 months
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25-item National Eye Institute Visual Function Questionnaire score
大体时间：Baseline (0), 6 months, and 12 months
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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
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Baseline (0), 6 months, and 12 months
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Treatment credibility scale score
大体时间：1 week and 12 months
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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.
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1 week and 12 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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