Age - Related Macular Degeneration (AMD)Early Phase 1NCT07121127
Effect of Fu's Subcutaneous Needling for Age-related Macular Degeneration
A Early Phase 1 study testing FSN+Vitamin supplement and Vitamin Supplements in people with Age - Related Macular Degeneration (AMD), run by Zhiming Yan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Age - Related Macular Degeneration (AMD)
- What is being tested?
- FSN+Vitamin supplement and Vitamin Supplements
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 7 Jul 2026to 9 Mar 2030
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- （ 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.
Who cannot join
- （ 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
- Being tested
- FSN+Vitamin supplement, Vitamin Supplements
- Keywords
- Fu's subcutaneous needling, age-related macular degeneration, OCTA
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSN+Vitamin supplementCombination product
Fu's subcutaneous needling with oral Vitamin C and vitamin E supplements
Vitamin SupplementsDrug
oral Vitamin C and vitamin E supplements
| Study group | Role | What they receive |
|---|---|---|
| Fu's subcutaneous needling group | Experimental | Fu's subcutaneous needling group with oral Vitamin C and vitamin E supplements Receives: Combination Product: FSN+Vitamin supplement |
| Control group | Other | oral Vitamin C and vitamin E supplements Receives: Drug: Vitamin Supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 14
Secondary outcomes (4)
Best Corrected Visual Acuity
Measuring vision at different time points compared with the primary outcome
Measured: 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
The NEI-VFQ-25 is a 25-item version questionnaire of the NEI-VFQ (National Eye Institute Visual Functioning Questionnaire),widely applied in ophthalmic studies including cataract and macular degeneration, with established reliability and validity. The Chinese version was created through cultural adaptation and professional translation. This study employs the version provided by Zhongshan Ophthalmic Center, Sun Yat-sen University.The questionnaire comprises two subscales: visual function (12 items) and quality of life (13 items). Each item scores from 0(worst) to 100(best) , where higher scores indicate better quality of life. Different from the English original's 5/6-point scale, the Chinese version converted to 4 point scale scoring follows a reverse-calculation method: each question's score equals 4 points minus the points selected. Domain scores are summed to generate the total visual function score.
Measured: both groups:baseline, end of FSN treatment week (day 14) follow-up day (day 28)
OCTA metrics
The SPECTRALIS OCT Angiography Module (Heidelberg Engineering) was utilized for fundus blood flow signal acquisition. FAZ,VD,CMT and CT will be collected as OCTA metrics of dAMD.The"FAZ Measurement" function will automatically quantify the foveal avascular zone (FAZ) area (mm²), corresponding to the superficial capillary plexus (SCP) of the macula ,and the "Density"function quantifies vessel density (VD) and automatically generates an en face projection map, providing the percentage of vascular area occupancy across the entire macula, with regional analyses of the fovea, parafovea, and temporal/superior/nasal/inferior macular sectors.The digital calipers tool within the OCT software was utilized to measure central foveal thickness (CFT) and central macular thickness (CMT).Choroid thickness (CT) will be measured vertical distance from the outer edge of the retinal pigment epithelium to the choroidal-scleral interface manually.
Measured: baseline ,end of the FSN treatment week (day 14)
Visual field
The Humphrey Field Analyzer enables precise quantitative measurement of retinal light sensitivity thresholds with SITA Standard program 10-2, specifically applicable for macular field testing.Operators perform visual field examinations via touchscreen or keyboard interface at pre-treatment, post-treatment, and follow-up phases. During testing, the patient remains seated with the non-tested eye occluded, stabilizes their chin and fixates on the central target of the gaze tracking system. Each perceived light stimulus triggers a press of the handheld response button. If patients feel tired, a prolonged button press can activate a pause, allowing them to rest before resuming the measurement.
Measured: both groups:baseline, end of FSN treatment week (day 14) follow-up day (day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start7 Jul 2026 (estimated)
- Primary completion8 Aug 2029 (estimated)
- Study completion9 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age - Related Macular Degeneration (AMD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiming Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiming Yan, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Investigators
- Jian Sun, Principal investigator, Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121127
- Sponsor's protocol ID
- ZF2025-237-01
- Status last verified
- Jul 2025
- First submitted
- 1 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Paper publication or Resman
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fu's Subcutaneous Needling for Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07121127
- Acronym / sponsor ID
- ZF2025-237-01
- Conditions
- Age - Related Macular Degeneration (AMD)
- Keywords
- Fu's subcutaneous needling, age-related macular degeneration, OCTA
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Zhiming YanUniversity, hospital or other
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- 8 Aug 2029 (estimated)
- Study completion
- 9 Mar 2030 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fu's subcutaneous needling group | Experimental | Combination Product: FSN+Vitamin supplementFu's subcutaneous needling group with oral Vitamin C and vitamin E supplements |
| Control group | Other | Drug: Vitamin Supplementsoral Vitamin C and vitamin E supplements |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- （ 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.
Key exclusion criteria (1 listed)
- （ 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FSN+Vitamin supplementFu's subcutaneous needling with oral Vitamin C and vitamin E supplements | Combination product | Fu's subcutaneous needling group |
| Vitamin Supplementsoral Vitamin C and vitamin E supplements | Drug | Control group |
Primary outcome
Best Corrected Visual Acuity
Time frame: Day 14
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.
4 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Yes. Paper publication or Resman
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Sun principal investigator
Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FSN+Vitamin supplement and Vitamin Supplements in people with Age - Related Macular Degeneration (AMD), run by Zhiming Yan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Sun M.D. (13580504600, sunj3610@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.