AMD
Conditions
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.
Interventions
DRUGSanhuang Jingshiming/Pills placebo
Ranibizumab: 1 dose/study eye (Screening/Baseline), then PRN injections
Sponsors
Tasly Pharmaceutical Group Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 50 to 85 years old (inclusive of 50 and 85 years old) 2. Meets the Western medical diagnostic criteria for neovascular age-related macular degeneration 3. Meets the TCM syndrome differentiation criteria for Qi-Yin Deficiency with Phlegm-Blood Stasis Intermingling Syndrome 4. The study eye is diagnosed with nAMD and the disease is in the active phase 5. BCVA of the study eye assessed by the ETDRS visual acuity chart ranges from 25 to 78 letters 6. Voluntarily participates in the clinical trial, signs the ICF, and is able to understand and comply with the trial procedures
Exclusion criteria
1. 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 2. Patients with pure PED in the study eye 3. Patients with subfoveal structural destruction or subfoveal fibrosis/scars/RPE tear/GA in the study eye 4. 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 5. Patients with CRT ≥ 700 μm in the study eye as assessed by OCT 6. 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 7. Patients planning to undergo any intraocular surgery on the study eye during the trial period 8. Patients who received pharmacologic treatment for nAMD within 2 weeks prior to randomization 9. Patients who received intravitreal anti-vascular endothelial growth factor therapy on the study eye within 4 months prior to randomization 10. Patients who received photodynamic therapy , laser photocoagulation, macular surgery, transpupillary thermotherapy , or corticosteroid therapy on the study eye within 6 months prior to randomization 11. Patients who underwent any intraocular or periocular surgery (excluding eyelid surgery) on the study eye within 3 months prior to randomization 12. Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg while on regular antihypertensive medication) 13. 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 14. 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 15. 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 16. Presence of any contraindications listed in the package insert of ranibizumab injection (Lucentis®) or other anti-VEGF injections 17. Suspected allergy to any study drug 18. 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 19. Participation in another interventional clinical trial within 3 months prior to randomization 20. Other reasons deemed unsuitable for participation in this clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants with ranibizumab injections | 24 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Change in CRT from baseline | 24 weeks | — |
| Proportion of participants with new macular hemorrhage | 24 weeks | — |
| Change in maximum macular hemorrhage area | 24 weeks | — |
| Change in NEI VFQ-25 score from baseline | 24 weeks | 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. |
| Change in TCM syndrome score from baseline | 24 weeks | 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. |
| Change in individual TCM syndrome score items from baseline | 24 weeks | 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. |
| Proportion of participants by TCM syndrome efficacy | 24 weeks | (clinical cure/marked effect/effective/ineffective） |
Countries
China
Contacts
CONTACTRui Liu
Outcome results
None listed