Effect of Fu's Subcutaneous Needling for Age-related Macular Degeneration
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FSN+Vitamin supplement, Vitamin Supplements.
- Who it may be relevant to
- Registry conditions: Age - Related Macular Degeneration (AMD). Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- Best Corrected Visual Acuity [Time frame: Day 14]
Secondary outcome measures (4)
- Best Corrected Visual Acuity [Time frame: 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 [Time frame: both groups:baseline, end of FSN treatment week (day 14) follow-up day (day 28)]
- OCTA metrics [Time frame: baseline ,end of the FSN treatment week (day 14)]
- Visual field [Time frame: both groups:baseline, end of FSN treatment week (day 14) follow-up day (day 28)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07121127 · ZF2025-237-01