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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active stimulation | Experimental |
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| Sham stimulation | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pterygopalatine ganglion stimulation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who completed the trial | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | From enrollment to 12 months | |
| Choroidal structure | -7 to 0 days, 1, 3, 6, 9, and 12 months | |
| Retinal sensitivity |
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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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiehe Kong, MD | Contact | 021-13621775647 | ynomrahkong@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Research Institute of Acupuncture and Meridian | Shanghai | 200030 | China |
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| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Sham pterygopalatine ganglion stimulation | Procedure | 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. |
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| 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 | 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 | 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 |