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AMDPhase 3NCT07269769

A Clinical Trial Evaluating the Efficacy and Safety of Sanhuang Jingshiming Pills in the Treatment of nAMD

A Phase 3 study of AMD, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The purpose of the TSL-TCM-SHJSMW-Ⅲ study is to study the efficacy and safety of Sanhuang Jingshiming Pills in subjects with Neovascular Age-Related Macular Degeneration. Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
AMD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
1 siteChina
Study dates
30 Apr 2026to 31 Dec 2031
Phase
Phase 3
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

  • Aged 50 to 85 years old (inclusive of 50 and 85 years old)
  • Meets the Western medical diagnostic criteria for neovascular age-related macular degeneration
  • Meets the TCM syndrome differentiation criteria for Qi-Yin Deficiency with Phlegm-Blood Stasis Intermingling Syndrome
  • The study eye is diagnosed with nAMD and the disease is in the active phase
  • BCVA of the study eye assessed by the ETDRS visual acuity chart ranges from 25 to 78 letters
  • Voluntarily participates in the clinical trial, signs the ICF, and is able to understand and comply with the trial procedures

Who cannot join

  • The study eye is complicated with pathologic myopia, high myopia, or secondary MNV caused by other definite diseases, glaucoma, diabetic retinopathy , retinal artery/vein occlusion , optic neuropathy (optic neuritis, optic atrophy, papilledema), macular hole, acute phase of intraocular inflammation, or other ocular diseases
  • Patients with pure PED in the study eye
  • Patients with subfoveal structural destruction or subfoveal fibrosis/scars/RPE tear/GA in the study eye
  • Patients whose FP of the study eye shows a total macular lesion area > 9 disc areas (total lesion area is defined as the sum of the areas of MNV, atrophy, scars, and fibrosis); or patients whose FP of the study eye shows a maximum macular hemorrhage area > 4 disc areas
  • Patients with CRT ≥ 700 μm in the study eye as assessed by OCT
  • Patients with opaque refractive media (e.g., vitreous hemorrhage, cataract) in the study eye precluding adequate visualization of the fundus, or with a history of vitrectomy
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  • Patients planning to undergo any intraocular surgery on the study eye during the trial period
  • Patients who received pharmacologic treatment for nAMD within 2 weeks prior to randomization
  • Patients who received intravitreal anti-vascular endothelial growth factor therapy on the study eye within 4 months prior to randomization
  • Patients who received photodynamic therapy , laser photocoagulation, macular surgery, transpupillary thermotherapy , or corticosteroid therapy on the study eye within 6 months prior to randomization
  • Patients who underwent any intraocular or periocular surgery (excluding eyelid surgery) on the study eye within 3 months prior to randomization
  • Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg while on regular antihypertensive medication)
  • History of major cardiovascular or cerebrovascular diseases, including but not limited to: ① history of myocardial infarction (MI), coronary angioplasty or bypass surgery, valvular heart disease or valvular repair, clinically significant and treatment-requiring arrhythmia, unstable angina, transient ischemic attack (TIA), cerebrovascular accident (CVA), etc., within 6 months prior to randomization; ② congestive heart failure (CHF) with New York Heart Association (NYHA) classification of Grade Ⅲ or Ⅳ
  • Laboratory test abnormalities as follows: ① platelet count ≤ 100 × 10⁹/L; ② International Normalized Ratio (INR) ≥ 1.5; ③ total bilirubin (TBIL) > 2 × upper limit of normal (ULN); ④ alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 × ULN; ⑤ serum creatinine (Scr) > 1.5 × ULN
  • Patients with severe and unstable diseases of the mental, neurological, respiratory, digestive, renal, metabolic, immune, hematologic, or other systems, as well as malignant tumors, who are assessed by the investigator as unsuitable for participation in this clinical trial
  • Presence of any contraindications listed in the package insert of ranibizumab injection (Lucentis®) or other anti-VEGF injections
  • Suspected allergy to any study drug
  • Pregnant or lactating females; males or females who plan to conceive within 30 days from signing the ICF to the end of the trial, or who cannot use effective contraceptive measures
  • Participation in another interventional clinical trial within 3 months prior to randomization
  • Other reasons deemed unsuitable for participation in this clinical trial by the investigator

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rui Liu contact

022-86343626

liurui383@taslypharma.com

China1 site

  • Beijing Hospital

    Beijing

    Hong Dai, Doctor, 13910280398, Dai-hong@x263.net

Other trials in China

About this study

Official title: A Phase III , Randomized, Double-blind, Placebo-Controlled, Ranibizumab Injection Loading, Multicenter Clinical Trial Comparing the Efficacy and Safety of Sanhuang Jingshiming Pills in Subjects With nAMD

The purpose of the TSL-TCM-SHJSMW-Ⅲ study is to study the efficacy and safety of Sanhuang Jingshiming Pills in subjects with Neovascular Age-Related Macular Degeneration.

Conditions
AMD
Being tested
Sanhuang Jingshiming/Pills placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sanhuang Jingshiming/Pills placeboDrug

    Also called Ranibizumab

    Ranibizumab: 1 dose/study eye (Screening/Baseline), then PRN injections

Study groups in NCT07269769
Study groupRoleWhat they receive
Experimental GroupExperimentalSanhuang Jingshiming Pills，1 sachet/dose, bid
Receives: Drug: Sanhuang Jingshiming/Pills placebo
Placebo GroupPlacebo comparatorPlacebo，1 sachet/dose, bid
Receives: Drug: Sanhuang Jingshiming/Pills placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with ranibizumab injections

    Measured: 24 weeks

Secondary outcomes (12)

  1. Mean number of ranibizumab injections

    Measured: 24 weeks

  2. Mean days between second ranibizumab injection and baseline

    Measured: 24 weeks

  3. Change in BCVA from baseline

    Measured: 24 weeks

  4. Proportion of participants with BCVA decrease ≥5/≥10/≥15 letters

    Measured: 24 weeks

  5. Change in lesion site thickness

    Measured: 24 weeks

  6. Change in CRT from baseline

    Measured: 24 weeks

  7. Proportion of participants with new macular hemorrhage

    Measured: 24 weeks

  8. Change in maximum macular hemorrhage area

    Measured: 24 weeks

  9. Change in NEI VFQ-25 score from baseline

    The Visual Function Questionnaire 25（NEI VFQ-25） has a maximum score of 100 and a minimum score of 0. The higher the score, the better vision.

    Measured: 24 weeks

  10. Change in TCM syndrome score from baseline

    There are a total of 5 projects in Traditional Chinese Medicine syndrome scale. The scale has a maximum score of 15 and a minimum score of 0. The higher the score, the more severe the disease.

    Measured: 24 weeks

  11. Change in individual TCM syndrome score items from baseline

    There are a total of 5 projects in Traditional Chinese Medicine syndrome scale. which 2 primary symptoms scored from 0 to 6 points，and 3 secondary symptoms scored from 0 to 1 point. The higher the score, the more severe the disease.

    Measured: 24 weeks

  12. Proportion of participants by TCM syndrome efficacy

    (clinical cure/marked effect/effective/ineffective）

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2025
  2. Study start30 Apr 2026 (estimated)
  3. Primary completion31 Dec 2031 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07269769
Sponsor's protocol ID
TSL-TCM-SHJSMW-Ⅲ
Status last verified
Nov 2025
First submitted
25 Nov 2025
Last updated
8 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study of AMD, run by Tasly Pharmaceutical Group Co., Ltd at 1 site in China.

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 6 inclusion and 20 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Rui Liu (022-86343626, liurui383@taslypharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with ranibizumab injections (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07269769.

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 8 Apr 2026.

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