Pterygopalatine Ganglion Stimulation for the Treatment of Geographic Atrophy
29 de abril de 2026 actualizado por: 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
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
62
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Xiehe Kong, MD
- Número de teléfono: 021-13621775647
- Correo electrónico: ynomrahkong@163.com
Ubicaciones de estudio
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Shanghai, Porcelana, 200030
- Shanghai Research Institute of Acupuncture and Meridian
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Contacto:
- Xiehe Kong, MD
- Número de teléfono: 021-13621775647
- Correo electrónico: ynomrahkong@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador falso: Estimulación simulada
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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.
Otros nombres:
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Experimental: Estimulación activa
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Proportion of participants who completed the trial
Periodo de tiempo: At 12 months
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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.
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At 12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of adverse events
Periodo de tiempo: From enrollment to 12 months
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From enrollment to 12 months
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Choroidal structure
Periodo de tiempo: -7 to 0 days, 1, 3, 6, 9, and 12 months
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-7 to 0 days, 1, 3, 6, 9, and 12 months
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Retinal sensitivity
Periodo de tiempo: Baseline (0), 6 months, and 12 months
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Baseline (0), 6 months, and 12 months
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Standard and low-luminance best corrected visual acuity
Periodo de tiempo: -7 to 0 days, 1, 3, 6, 9, and 12 months
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-7 to 0 days, 1, 3, 6, 9, and 12 months
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Geographic atrophy lesion area and square root-transformed geographic atrophy area
Periodo de tiempo: -7 to 0 days, 6 months, and 12 months
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-7 to 0 days, 6 months, and 12 months
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Contrast sensitivity
Periodo de tiempo: Baseline (0), 1, 3, 6, 9, and 12 months
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Baseline (0), 1, 3, 6, 9, and 12 months
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25-item National Eye Institute Visual Function Questionnaire score
Periodo de tiempo: Baseline (0), 6 months, and 12 months
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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
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Baseline (0), 6 months, and 12 months
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Treatment credibility scale score
Periodo de tiempo: 1 week and 12 months
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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.
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1 week and 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de junio de 2026
Finalización primaria (Estimado)
1 de junio de 2028
Finalización del estudio (Estimado)
31 de julio de 2028
Fechas de registro del estudio
Enviado por primera vez
7 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
29 de abril de 2026
Publicado por primera vez (Actual)
6 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
29 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ShanghaiIAMM2026011
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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