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Pterygopalatine Ganglion Stimulation for the Treatment of Geographic Atrophy

29. april 2026 opdateret af: Shanghai Institute of Acupuncture, Moxibustion and Meridian

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

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

62

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Kina
      • Shanghai, Kina, 200030
        • Shanghai Research Institute of Acupuncture and Meridian
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Sham-komparator: Sham stimulering
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.
Andre navne:
  • Sham sphenopalatine ganglion stimulation
Eksperimentel: Aktiv stimulering
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.
Andre navne:
  • Sphenopalatine ganglion stimulation

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants who completed the trial
Tidsramme: 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.
At 12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of adverse events
Tidsramme: From enrollment to 12 months
From enrollment to 12 months
Choroidal structure
Tidsramme: -7 to 0 days, 1, 3, 6, 9, and 12 months
-7 to 0 days, 1, 3, 6, 9, and 12 months
Retinal sensitivity
Tidsramme: Baseline (0), 6 months, and 12 months
Baseline (0), 6 months, and 12 months
Standard and low-luminance best corrected visual acuity
Tidsramme: -7 to 0 days, 1, 3, 6, 9, and 12 months
-7 to 0 days, 1, 3, 6, 9, and 12 months
Geographic atrophy lesion area and square root-transformed geographic atrophy area
Tidsramme: -7 to 0 days, 6 months, and 12 months
-7 to 0 days, 6 months, and 12 months
Contrast sensitivity
Tidsramme: Baseline (0), 1, 3, 6, 9, and 12 months
Baseline (0), 1, 3, 6, 9, and 12 months
25-item National Eye Institute Visual Function Questionnaire score
Tidsramme: 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
Baseline (0), 6 months, and 12 months
Treatment credibility scale score
Tidsramme: 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.
1 week and 12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

31. juli 2028

Datoer for studieregistrering

Først indsendt

7. april 2026

Først indsendt, der opfyldte QC-kriterier

29. april 2026

Først opslået (Faktiske)

6. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. april 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ShanghaiIAMM2026011

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Geografisk atrofi

Kliniske forsøg med Pterygopalatine ganglion stimulation

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