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

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

Overview

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.

Interventions

• Drug Sanhuang Jingshiming/Pills placebo
  Ranibizumab: 1 dose/study eye (Screening/Baseline), then PRN injections

Primary outcome measures

• Proportion of participants with ranibizumab injections [Time frame: 24 weeks]

Secondary outcome measures (12)

• Mean number of ranibizumab injections [Time frame: 24 weeks]
• Mean days between second ranibizumab injection and baseline [Time frame: 24 weeks]
• Change in BCVA from baseline [Time frame: 24 weeks]
• Proportion of participants with BCVA decrease ≥5/≥10/≥15 letters [Time frame: 24 weeks]
• Change in lesion site thickness [Time frame: 24 weeks]
• Change in CRT from baseline [Time frame: 24 weeks]
• Proportion of participants with new macular hemorrhage [Time frame: 24 weeks]
• Change in maximum macular hemorrhage area [Time frame: 24 weeks]
• Change in NEI VFQ-25 score from baseline [Time frame: 24 weeks]
• Change in TCM syndrome score from baseline [Time frame: 24 weeks]
• Change in individual TCM syndrome score items from baseline [Time frame: 24 weeks]
• Proportion of participants by TCM syndrome efficacy [Time frame: 24 weeks]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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

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

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Hospital — Beijing

Identifiers

NCT: NCT07269769 · TSL-TCM-SHJSMW-Ⅲ

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗