NCT07269769
Not yet recruiting
Phase 3
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
Tasly Pharmaceutical Group Co., Ltd1 site in 1 country450 target enrollmentStarted: April 30, 2026Last updated:
InterventionsSanhuang Jingshiming/Pills placebo
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Proportion of participants with ranibizumab injections
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Experimental Group
Experimental
Sanhuang Jingshiming Pills，1 sachet/dose, bid
Intervention: Sanhuang Jingshiming/Pills placebo (Drug)
Placebo Group
Placebo Comparator
Placebo，1 sachet/dose, bid
Intervention: Sanhuang Jingshiming/Pills placebo (Drug)
Outcomes
Primary Outcomes
Proportion of participants with ranibizumab injections
Time Frame: 24 weeks
Secondary Outcomes
- 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)
- Change in TCM syndrome score from baseline(24 weeks)
- Change in individual TCM syndrome score items from baseline(24 weeks)
- Proportion of participants by TCM syndrome efficacy(24 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Clinical study for ''Shuang-Shen San-Jie'' Formula in the prevention and treatment of postoperative recurrence of GlioblastomaGlioblastomaITMCTR2000003185Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Not yet recruiting
Not Applicable
Mailuo Shutong Pills for Diabetic Wound Healing: A Multicenter Randomized TrialNCT07258381Peking University Third Hospital56
Completed
Phase 3
The Clinical Trial of Chinese Herbal Medicine (SaiLuoTong) CapsuleVascular DementiaNCT03789760Shineway Pharmaceutical Co.,Ltd493
Unknown
Not Applicable
Clinical Trial of Jinzhen Oral Liquid in Treating Children With COVID-19 InfectionCOVID-19Child, OnlyNCT05507489The Affiliated Hospital of Qingdao University240
Recruiting
Phase 3
A Study of Jincaopian Tablets on Chronic Pelvic Pain After Pelvic Inflammatory DiseaseChronic Pelvic PainNCT05970783Beijing Konruns Pharmaceutical Co., Ltd.414