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NOT YET RECRUITING

NCT07121127

EARLY_PHASE1

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

Sponsor: Zhiming Yan

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-07-07

Completion Date

2030-03-09

Last Updated

2025-08-13

Healthy Volunteers

Conditions

Interventions

COMBINATION_PRODUCT

FSN+Vitamin supplement

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

DRUG

Vitamin Supplements

oral Vitamin C and vitamin E supplements

Inclusion Criteria: （ 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. Exclusion Criteria: （ 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.