An Innovative Chinese Herbal Formula for Macular Edema
Status:
Not yet recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
Macular edema (ME) is caused by hyperpermeability of retinal vessels and/or decreased efflux
of fluid across the retinal pigment epithelium induced by outer/inner blood-retinal barrier
dysfunction (BRB). It is most commonly seen following many diseases such as diabetes mellitus
(DM), intraocular surgery, uveitis, retinal vein occlusion, and posterior segment
inflammatory disease. An estimated 11% of patients with DM develop diabetic macular edema
(DME). While the overall prevalence of DME among patients with DM aged 20 to 79 years is
approximately 7.5%, the risk increases over time. Currently, there is no cure for ME.
Chinese medicine (CM) is widely used to manage ME in China and other East Asian countries.
Among them, Shenling Baizhu San (SBS) is one of the most commonly used formulae. In this
proposal, a randomized, double-blind, placebo-controlled, multicenter clinical trial will be
undertaken to evaluate the efficacy and safety of modified SBS (mSBS) developed by the
project team for the treatment of ME.
Eligible subjects will be recruited and assigned randomly to receive orally mSBS or placebo
twice a day for 12 consecutive weeks, with follow-up for another 4 weeks after stopping the
treatment to observe the duration of efficacy.