Feasibility and Safety Evaluation of Pterygopalatine Ganglion Stimulation in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Proportion of participants who completed the trial
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active stimulation
干预措施: Pterygopalatine ganglion stimulation (Procedure)
Sham stimulation
干预措施: Sham pterygopalatine ganglion stimulation (Procedure)
结局指标
主要结局
Proportion of participants who completed the trial
时间窗: 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.
次要结局
- Incidence of adverse events(From enrollment to 12 months)
- Choroidal structure(-7 to 0 days, 1, 3, 6, 9, and 12 months)
- Retinal sensitivity(Baseline (0), 6 months, and 12 months)
- Standard and low-luminance best corrected visual acuity(-7 to 0 days, 1, 3, 6, 9, and 12 months)
- Geographic atrophy lesion area and square root-transformed geographic atrophy area(-7 to 0 days, 6 months, and 12 months)
- Contrast sensitivity(Baseline (0), 1, 3, 6, 9, and 12 months)
- 25-item National Eye Institute Visual Function Questionnaire score(Baseline (0), 6 months, and 12 months)
- Treatment credibility scale score(1 week and 12 months)