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

NCT07269769 | Not Yet Recruiting Phase 3

• 1 other identifier: TSL-TCM-SHJSMW-Ⅲ
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AMD

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with ranibizumab injections

  24 weeks

Secondary Outcomes (12)

• Mean number of ranibizumab injections

  24 weeks

• Mean days between second ranibizumab injection and baseline

  24 weeks

• Change in BCVA from baseline

  24 weeks

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

  24 weeks

• Change in lesion site thickness

  24 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Sanhuang Jingshiming Pills，1 sachet/dose, bid

Drug: Sanhuang Jingshiming/Pills placebo

Placebo Group

PLACEBO COMPARATOR

Placebo，1 sachet/dose, bid

Drug: Sanhuang Jingshiming/Pills placebo

Interventions

Sanhuang Jingshiming/Pills placebo DRUG

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

Also known as: Ranibizumab

Experimental Group; Placebo 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:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

Beijing Hospital

Beijing, China

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Rui Liu

CONTACT

022-86343626; liurui383@taslypharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: April 30, 2026
• Primary Completion (Estimated): December 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: April 8, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)