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

ConditionAMD
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50-85
SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Sanhuang Jingshiming/Pills placebo

Treatment groups

450 Participants
are divided into 2 treatment groups