Effect of Fu's Subcutaneous Needling for Age-related Macular Degeneration

NCT07121127 | Not Yet Recruiting Early Phase 1

• 1 other identifier: ZF2025-237-01
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pilot randomized controlled trial aims to evaluate the efficacy and safety of FSN in improving symptoms in patients with dAMD.38 eligible participants will be recruited and randomly assign them in a 1:1 ratio to the FSN group and the control group. Throughout the study, both groups will take oral vitamin C and vitamin E supplements for a total of 28 days. Participants in the FSN group will receive four treatment sessions over two weeks. Both groups will be assessed at the end of the FSN treating period during the mid-study period, with ocular blood flow dynamics measured using OCTA, followed by a two-week follow-up. The primary outcome of this trial is the change in visual acuity from baseline to week 2, with secondary outcomes including visual field, visual function scale, macular thickness, central avascular zone area vascular density, and choroidal thickness.

Conditions

Age - Related Macular Degeneration (AMD)

Keywords

Fu's subcutaneous needling; age-related macular degeneration; OCTA

Outcome Measures

Primary Outcomes (1)

• Best Corrected Visual Acuity

  The best corrected visual acuity at distance and near will be tested as the main outcome after 2-week treatment，which is the mid period of intervention.During vision testing, paticipants stand 5 meters from the chart with one eye covered. The chart height is adjusted so the 1.0 line aligns with their eye level. For near vision assessment, the subject positions themselves 25 cm from the vision chart with one eye occluded.

  Day 14

Secondary Outcomes (4)

• Best Corrected Visual Acuity

  FSN group:Baseline 2 days in FSN treatment period(days 4 and 11),follow-up day (day 28);Control group: Baseline follow-up day (day 28)

• Visual Function Questionnaire 25

  both groups:baseline, end of FSN treatment week (day 14) follow-up day (day 28)

• OCTA metrics

  baseline ,end of the FSN treatment week (day 14)

• Visual field

  both groups:baseline, end of FSN treatment week (day 14) follow-up day (day 28)

Study Arms (2)

Fu's subcutaneous needling group

EXPERIMENTAL

Fu's subcutaneous needling group with oral Vitamin C and vitamin E supplements

Combination Product: FSN+Vitamin supplement

Control group

OTHER

oral Vitamin C and vitamin E supplements

Drug: Vitamin Supplements

Interventions

FSN+Vitamin supplement COMBINATION_PRODUCT

Fu's subcutaneous needling with oral Vitamin C and vitamin E supplements

Fu's subcutaneous needling group

Vitamin Supplements DRUG

oral Vitamin C and vitamin E supplements

Control group

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• （ 1 ） Age between 50 and 85 years old with no gender restrictions （ 2 ） Meets the diagnostic criteria for dry age-related macular degeneration (AMD) as outlined in the 2023 Chinese Clinical Practice Guidelines for Age-Related Macular Degeneration （ 3 ） Both monocular and binocular cases of dry AMD are included. For patients with bilateral lesions the experimental group is based on the patient's preferred eye (if both eyes are preferred the average of the data collected from both eyes is included in the analysis) （ 4 ） Participants must voluntarily consent and sign an informed consent form and be willing to cooperate with follow-up visits.

You may not qualify if:

• （ 1 ） Serious eye diseases that significantly affect the condition of the fundus excluding dry macular degeneration including fundus lesions such as fundus hemorrhage and wet macular degeneration; or concomitant eye diseases requiring immediate treatment such as acute glaucoma; severe opacity of the refractive media such as mature cataracts （ 2 ） In distance vision testing the patient cannot discern the direction of the largest character at a distance of 1 meter from the distance vision chart （ 3 ） Participants who have undergone eye surgery within the past six months （ 4 ） Participants with non-ophthalmic conditions that may severely affect vision such as large-area cerebral infarction cerebral hemorrhage diabetes thyroid eye disease vitamin A deficiency or Sjögren's syndrome （ 5 ） Pregnant or lactating women （ 6 ） Participants with severe anemia renal failure acute phase of cardiovascular disease implanted cardiac pacemaker thrombocytopenia or other hematological conditions with a high risk of severe subcutaneous bleeding or requiring skin puncture （ 7 ） Participants who have taken medications or consumed foods that affect ocular blood supply within the past week such as caffeine atropine or other treatments for macular degeneration （ 8 ） Participants who require contact lenses.

Sponsors & Collaborators

• Zhiming Yan: lead

MeSH Terms

Conditions

Macular Degeneration

Interventions

Geritol

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jian Sun

  Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Sun M.D.

CONTACT

13580504600; sunj3610@163.com

Ming Zhi Yan

CONTACT

15817400383; 2369680940@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: postgraduate of the Second Clinical College of Guangzhou University of Chinese Medicine

Study Record Dates

• First Submitted: August 1, 2025
• First Posted: August 13, 2025
• Study Start (Estimated): July 7, 2026
• Primary Completion (Estimated): August 8, 2029
• Study Completion (Estimated): March 9, 2030
• Last Updated: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR