Pterygopalatine Ganglion Stimulation for the Treatment of Geographic Atrophy
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
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Xiehe Kong, MD
- 전화번호: 021-13621775647
- 이메일: ynomrahkong@163.com
연구 장소
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Shanghai, 중국, 200030
- Shanghai Research Institute of Acupuncture and Meridian
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연락하다:
- Xiehe Kong, MD
- 전화번호: 021-13621775647
- 이메일: ynomrahkong@163.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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가짜 비교기: 가짜 자극
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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.
다른 이름들:
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실험적: 적극적인 자극
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Proportion of participants who completed the trial
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Incidence of adverse events
기간: From enrollment to 12 months
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From enrollment to 12 months
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Choroidal structure
기간: -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
기간: 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
기간: -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
기간: -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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- ShanghaiIAMM2026011
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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Pterygopalatine ganglion stimulation에 대한 임상 시험
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