Pterygopalatine Ganglion Stimulation for the Treatment of Geographic Atrophy

NCT07570355 | Not Yet Recruiting

• 1 other identifier: ShanghaiIAMM2026011
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Geographic Atrophy

Keywords

Geographic Atrophy; Pterygopalatine Ganglion; Sphenopalatine Ganglion; Clinical Trial; Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• 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

Study Arms (2)

Active stimulation

EXPERIMENTAL

Procedure: Pterygopalatine ganglion stimulation

Sham stimulation

SHAM COMPARATOR

Procedure: Sham pterygopalatine ganglion stimulation

Interventions

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.

Also known as: Sphenopalatine ganglion stimulation

Active 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.

Also known as: Sham sphenopalatine ganglion stimulation

Sham stimulation

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Institute of Acupuncture, Moxibustion and Meridian: lead

Study Sites (1)

Shanghai Research Institute of Acupuncture and Meridian

Shanghai, 200030, China

Location

MeSH Terms

Conditions

Geographic Atrophy; Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Xiehe Kong, MD

CONTACT

021-13621775647; ynomrahkong@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CN (1)