OBJECTIVE To evaluate the clinical efficacy of Ziyin Mingmu Formula in treating dry age-related macular degeneration (AMD) with liver and kidney deficiency.

METHODS Sixty-six patients with dry AMD of liver and kidney deficiency type were randomly divided into an experimental group and a control group, 33 cases in each group. Except for shedding cases and excluding cases, 30 cases in each group were completed. The control group was treated with Laishiding capsules orally, and the experimental group was treated with Ziyin Mingmu Formula granules orally. Both groups were treated for 3 months. Before and after treatment, changes in best corrected visual acuity (BCVA), fundus autofluorescence (AF), drusen area, and TCM syndrome scores were observed in both groups. Optical coherence tomography (OCTA) was used to detect changes in choroidal capillary (CC) perfusion area and mean choroidal thickness. Serum total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) levels were also measured. Liver and kidney function were measured in both groups before and after treatment, and adverse events were observed during treatment.

RESULTS After treatment, the experimental group showed an increase in BCVA, a significant decrease in fundus AF, and a significant reduction in drusen area (P<0.01), while the control group showed no significant changes in BCVA, fundus AF, or drusen area. The experimental group had a higher BCVA and a smaller drusen area than the control group (P<0.05). The experimental group showed a significant decrease in all TCM syndromes and total scores (P<0.05, P<0.01), while the control group showed a significant decrease in insomnia, soreness and weakness of waist and knees, dry mouth and pharyngeal dryness and total scores (P<0.05, P<0.01). The experimental group showed better changes in blurred vision, insomnia, soreness and weakness of waist and knees, dry mouth and pharyngeal dryness scores than the control group (P<0.05, P<0.01). The total effective rate of TCM clinical efficacy in the experimental group was 93.33%, significantly higher than the 56.67% in the control group (P<0.01). The experimental group also showed an increase in the CC perfusion area in the T3 region and the average thickness of the choroid in the N3 region (P<0.05), the CC perfusion area in the T3 region of the experimental group was greater than that in the control group (P<0.05); the serum LDL-C level was increased and the HDL-C level was decreased in the experimental group (P<0.05), while the serum TC and LDL-C levels in the experimental group were higher than those in the control group, and the HDL-C level was lower than that in the control group (P<0.05). There were no significant changes in liver and kidney function before and after treatment in either group, and no drug-related adverse events occurred in either group during the treatment period.

CONCLUSION Ziyin Mingmu Formula can significantly improve the clinical symptoms of patients with dry AMD of liver and kidney deficiency type. Its mechanism may be related to increasing the perfusion area of CC and improving lipid metabolism.