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Acupuncture in the treatment of neovascular age-related macular degeneration: a randomized, open-label trial

Registration number：

ITMCTR2024000361

Date of Last Refreshed on：

2024-09-03

Date of Registration：

2024-09-03

Registration Status：

Retrospective registration

Public title：

Acupuncture in the treatment of neovascular age-related macular degeneration: a randomized, open-label trial

English Acronym：

Scientific title：

Huoxue Tongluo acupuncture in the treatment of neovascular age-related macular degeneration: a randomized, open-label trial

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

wusun

Study leader：

wusun

Applicant telephone：

17801223057

Study leader's telephone：

17801223057

Applicant Fax：

Study leader's fax：

Applicant E-mail：

18717123259@163.com

Study leader's E-mail：

18717123259@163.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 1 Xiyuan Playground, Haidian District, Beijing

Study leader's address：

No. 1 Xiyuan Playground, Haidian District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Approved by ethic committee：

Approved No. of ethic committee：

2024XLA101-2

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Xiyuan Hospital of China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2024/7/15 0:00:00

Contact Name of the ethic committee：

010-62835646

Contact Address of the ethic committee：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Contact phone of the ethic committee：

010-62835646

Contact email of the ethic committee：

xyyirb@163.com

Primary sponsor：

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Primary sponsor's address：

No. 1 Xiyuan Playground Haidian District Beijing

Secondary sponsor：

Country：

china

Province：

beijing

City：

Institution
hospital：

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Address：

No. 1 Xiyuan Playground Haidian District Beijing

Source(s) of funding：

China Academy of Chinese Medical Sciences

Target disease：

Age-related macular degeneration

Target disease code：

Study type：

Interventional study

Study design：

Quasi-randomized controlled

Study phase：

Others

Objectives of Study：

To observe the efficacy and safety of acupuncture in the treatment of neovascular age-related macular degeneration

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① The age range is 50-80 years old; ② Meets the diagnostic criteria for nAMD: (a) Reduced visual acuity. There is discoid exudation in the macular area with repeated hemorrhages visible neovascularization and loss of macular central recess reflex. (b) Fundus fluorescence angiography shows: neovascularization with fluorescence leakage and occluded fluorescence in the hemorrhagic area; (c) ③ Best corrected visual acuity between 4 and 73 letters (EDTRS) approximately equal to 20/32 to 20/800 on the Snellen visual acuity scale; ④ Those who are capable of signing informed consent.

Exclusion criteria：

(1) A history of diabetic retinopathy retinal vein occlusion iridocyclitis macular tear retinal detachment and macular proptosis; (2) History of glaucoma history of ocular trauma; (3) History of vitreous surgery and PDT treatment; (4) Received anti-VEGF treatment 6 months before enrollment. (5) Combined with serious cardiac cerebrovascular hepatic and renal systemic diseases long-term use of anticoagulant drugs and coagulation disorders; (6) Patients with a history of metal allergy to acupuncture needles; patients with a history of needle-sickness; (7) Patients who are allergic to anti-VEGF drugs; (8) Patients with cognitive impairment who are unable to detect vision; (9) Pregnant women and those preparing for pregnancy; (10) Patients who are participating in other clinical trials.

Study execute time：

From 2024-07-15

To      2028-07-15

Recruiting time：

From 2024-07-15

To      2028-07-15

Interventions：

90

Group：

experimental group

Sample size：

Intervention：

acupuncture+Standard anti-VEGF therapy (3+PRN regimen)

Intervention code：

90

Group：

Standard treatment group

Sample size：

Intervention：

Standard anti-VEGF therapy (3+PRN regimen)

Intervention code：

Total sample size ： 180

Countries of recruitment
and research settings：

Country：

china

Province：

beijing

City：

Institution/hospital：

Xiyuan Hospital, China Academy of Chinese Medical Sciences

Level of the institution：

Class III, Class A hospital

Country：

china

Province：

beijing

City：

Institution/hospital：

DongfangHospital of Beijing University of Chinese Medicine

Level of the institution：

Class III Class A hospital

Country：

china

Province：

beijing

City：

Institution/hospital：

Guang 'anmen Hospital, China Academy of Chinese Medical Sciences

Level of the institution：

Class III, Class A hospital

Country：

china

Province：

beijing

City：

Institution/hospital：

China Academy of Chinese Medical Sciences Eye Hospital

Level of the institution：

Class III, Class A hospital

Outcomes：

Outcome：

Incidence of adverse events

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

incidence of subretinal fibrosis in one year

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

best-corrected visual acuity

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

central macular thickness

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Recruiting

50
Min age years
80
Max age years

Recruiting status：

Participant age：

Gender：

Both

Randomization Procedure (please state who generates the random number sequence and by what method)：

The GCP Center of Xiyuan Hospital was responsible for the development of the randomization scheme and the production of envelopes. SAS9.1 was applied for random grouping, and opaque randomization envelopes were used for random sequence allocation concealment. According to the chronological order of enrollment, the enrolled patients were randomly grouped and assigned to the experimental group and the control group in a 1:1 ratio, respectively.

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Available by contacting the author where appropriate

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

由第三方人员进行病例记录表(Case Record Form, CRF)记录并统一管理。

Data Managemen Committee：

Yes

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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