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Pterygopalatine Ganglion Stimulation for the Treatment of Geographic Atrophy

NCT07570355 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-05-06

No results posted yet for this study

Summary

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

Conditions

Interventions

PROCEDURE

Pterygopalatine ganglion stimulation

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.

PROCEDURE

Sham pterygopalatine ganglion stimulation

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.

Sponsors & Collaborators

  • Shanghai Institute of Acupuncture, Moxibustion and Meridian

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-06-01
Completion
2028-07-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07570355 on ClinicalTrials.gov