ObjectiveTo observe the safety and efficacy of Keluoxin capsules in the treatment of moderate to severe non-proliferative diabetic retinopathy (NPDR). MethodsAn open-label, multi-center, single-arm, phase Ⅱa clinical trial. From May 2014 to December 2016, the patients diagnosed with moderate to severe NPDR who received Keroxin treatment in General Hospital of Central Theater Command, Affiliated Eye Hospital to Nanchang University, Xiyuan Hospital of China Academy of Chinese Medical Sciences, and Eye Hospital China Academy of Chinese Medical Sciences were divided into moderate NPDR group and severe NPDR group. The baseline data of the patients were obtained, best-corrected visual acuity (BCVA), optical coherence tomography, fundus fluorescein angiography and fundus photography were performed. On the basis of maintaining the original diabetes treatment, all patients took Keluoxin capsules orally for 24 weeks; 24 weeks after treatment was used as the time point for evaluating the efficacy. BCVA letters, central macular thickness (CMT) and 6 mm diameter total macular volume (TMV), retinal vascular leakage area, and retinal non-perfusion (RNP) area within an average diameter of 6 mm were compared between the two groups at baseline and 24 weeks after treatment. Independent sample Mann-Whitney U test was used to compare continuous variables between groups. Categorical data were compared by χ2 test. ResultsA total of 60 NPDR patients and 60 eyes were included, 9 cases were lost to follow-up, and 51 cases and 51 eyes were finally included, including 37 eyes in the moderate NPDR group and 14 eyes in the severe NPDR group, respectively. At baseline, BCVA in moderate NPDR group and severe NPDR group were (80.1±6.8), (81.4±6.3) letters, respectively. CMT were (249.5±32.1), (258.9±22.2) μm, respectively. TMV were (8.79±1.09), (8.95±1.31) mm3, respectively. Retinal vascular leakage areas were (7.69±10.63), (10.45±7.65) mm2, respectively. RNP area were (2.48±5.74), (10.63±20.06) mm2, respectively. There were 11 (29.7%, 11/37) and 4 (28.6%, 4/14) eyes with diabetic macular edema (DME), respectively; 24 weeks after treatment, BCVA in moderate NPDR group and severe NPDR group increased by (1.3±5.2), (3.2±3.0) letters, respectively. Compared with baseline, there was a statistically significant difference in the severe NPDR group (t=－3.986, P=0.033). CMT were (252.1±45.6), (269.8±57.2) μm, respectively. There were no significant differences compared with baseline (t=－0.567, －0.925; P＞0.05). TMV were (9.96±1.16), (10.09±1.32) mm3, respectively. There were no significant differences compared with baseline (t=－0.996, －1.304; P＞0.05). Retinal vascular leakage area decreased (0.19±6.90), (1.98±7.52) mm2, respectively. There were no significant differences compared with baseline (t=0.168, 0.983; P＞0.05). RNP area were (3.01±6.47), (10.36±19.57) mm2, respectively. Compared with baseline, the differences were statistically significant (t=－1.267, 0.553; P＞0.05). There were 8 (21.6%, 8/37) and 3 (21.4%, 3/14) eyes with DME, respectively. Compared with baseline, the difference was statistically significant (χ2=11.919, 4.571; P=0.001, 0.033). ConclusionKeluoxin capsules can stabilize or improve BCVA, CMT, TMV and RNP area in patients with moderate and severe NPDR, and reduce the area of retinal vascular leakage.
ObjectiveTo explore the conversion treatment value of Faricimab in patients with neovascular age-related macular degeneration (nAMD) who had sub-optimal response to anti-vascular endothelial growth factor (VEGF) drug therapy, and to preliminarily evaluate its clinical effect. MethodsA retrospective clinical study. From March 2024 to January 2025, 25 patients (32 eyes) diagnosed with nAMD at Department of Ophthalmology of General Hospital of Central Theater Command were included in the study. All affected eyes were converted to receive Faricimab treatment due to sub-optimal response to previous anti-VEGF drug therapy. The treatment plan is to provide treatment as needed after the first injection based on the follow-up results. The best corrected visual acuity (BCVA) and swept-source optical coherence tomography angiography (SS-OCTA) were evaluated. BCVA examination was conducted using the Snellen visual acuity chart and converted to the logarithm of the minimum angle of resolutionn (logMAR) visual acuity for statistical analysis. The SS-OCTA system automatically calculates indicators such as central retinal thickness (CRT), choroidal neovascularization surface area (CSA), and choroidal neovascularization flow area (CFA). The main observations were made on the changes of BCVA, CSA, CFA, CRT and adverse reactions at 1, 3 and 6 months after treatment. A mixed linear model was adopted to compare the differences between each index and the baseline. ResultsAmong the 25 patients, 20 were male (80.0%, 20/25) and 5 were female (20.0%, 5/25). Age was (66.6±11.2) years old. The disease course was (41.2±36.4) months. Previously received anti-VEGF drug treatment (20.5±21.6) times, involving 2.2 types of drugs. Among the 32 eyes, 16 (50.0%), 11 (34.4%), and 7 (21.9%) eyes had subretinal fluid, intraretinal fluid, and both coexisting, respectively. At baseline, the logMAR BCVA of the affected eye was 0.67±0.41, the CSA and CFA were (7.46±6.27) and (3.26±2.59) mm2, respectively, and the CRT was (380.75±147.56) μm. At 1, 3, and 6 months after switching to Faricimab treatment, logMAR BCVA improved to 0.57±0.42, 0.55±0.41, and 0.50±0.35, respectively. The corresponding CSA were (6.36±6.10), (6.44±6.12), and (6.44±5.96) mm2. The corresponding CFA values were (2.79±2.50), (2.35±2.25), and (2.59±2.35) mm2. The corresponding CRT were (330.64±147.56), (329.44±130.73), (340.05±144.56) μm. Compared with the baseline, BCVA significantly improved at each time point after treatment, and CSA and CFA significantly decreased. The differences were statistically significant (P＜0.05). At 1 and 3 months after treatment, CRT was significantly lower than the baseline, and the difference was statistically significant (P=0.005, 0.025). During the follow-up period, the intraocular pressure of all affected eyes remained normal, and no serious adverse events such as intraocular infection occurred. ConclusionFor nAMD patients with poor response to anti-VEGF drug treatment, switching to Faricimab treatment can effectively improve the BCVA and anatomical structure (including CSA, CFA and CRT) of the affected eyes, and has good safety.