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NCT Number: NCT07570355

Pterygopalatine Ganglion Stimulation for the Treatment of Geographic Atrophy

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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Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Sphenopalatine ganglion stimulation

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.

Other names: Sham sphenopalatine ganglion stimulation

Primary outcomes

  1. Proportion of participants who completed the trial

    Time frame: 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.

Secondary outcomes

  1. Incidence of adverse events

    Time frame: From enrollment to 12 months

  2. Choroidal structure

    Time frame: -7 to 0 days, 1, 3, 6, 9, and 12 months

  3. Retinal sensitivity

    Time frame: Baseline (0), 6 months, and 12 months

  4. Standard and low-luminance best corrected visual acuity

    Time frame: -7 to 0 days, 1, 3, 6, 9, and 12 months

  5. Geographic atrophy lesion area and square root-transformed geographic atrophy area

    Time frame: -7 to 0 days, 6 months, and 12 months

  6. Contrast sensitivity

    Time frame: Baseline (0), 1, 3, 6, 9, and 12 months

  7. 25-item National Eye Institute Visual Function Questionnaire score

    Time frame: 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

  8. Treatment credibility scale score

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiehe Kong, MD

CONTACT

[email protected]

021-13621775647

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Registry information

Official study title

Feasibility and Safety Evaluation of Pterygopalatine Ganglion Stimulation in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Controlled Pilot Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 6, 2026
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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