Mingjing Granule in the treatment of neovascular age-related macular degeneration: a prospective, randomized, double-blind, placebo parallel controlled, multicenter clinical trial

Eye Hospital, China Academy of Chinese Medical Sciences0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

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•? Exudative changes due to active CNV lesions secondary to AMD in one eye or both eyes.
•? Up to the syndrome of TCM: Yin deficiency and blood stasis.
•? Aged 50 to 80 years.
•? The BCVA between 73 and 34 assessed by ETDRS charts(approximately 20/40-20/200 Snellen equivalent).
•? Agree to participate in the trial and provide written informed consent.

•?Those with PCV or complete scars due to AMD but without bleeding or exudation.
•?Those with high myopia, glaucoma, diabetic retinopathy, retinal vein occlusion, retinal artery occlusion, optic neuropath (optic neuritis, atrophy, papillary edema), macular hole or CNV due to other ocular fundus diseases; or with severe diseases in cardio-cerebrovessels, liver, hematopoietic systems, or severely life-threatening primary diseases or mental illness.
•?Unclear dioptric media in the study eye that affecting ocular fundus examination.
•?Those with creatinine the upper limit of normal, AST and/or ALT 2-fold the upper limitation of normal or above.
•?Previous or concomitant participation in another clinical study with investigational medicinal products or combined with similar Chinese medicine or other therapies(prior treatment of the study eye with intraocular anti-VEGF agents, corticosteroids, laser, eye surgery within 3 months prior to study entry).
•?Patients who the investigators deem to be ineligible for the study, such as unstable living environment, which may lead to loss of follow-up.

发起方

Eye Hospital, China Academy of Chinese Medical Sciences