Hui-Jun Qi1, Xiao-Xin Li1, Jun-Yan Zhang2, Ming-Wei Zhao1. 1. Department of Ophthalmology, People's Hospital, Peking University, Beijing 100044, China. 2. Clinical Study Consultant, Bothwin Pte. Ltd., Shanghai 200232, China; Branch of Clinical Epidemiology and Evidence-Based Medicine, Shanghai Medical Association, Shanghai 200240, China.
Abstract
AIM: To evaluate the clinical efficacy and safety of ranibizumab for wet age-related macular degeneration (wAMD) in Chinese patients and to determine the mean number of injections administered over one year of follow-up. METHODS: This single centre, retrospective observational case series study included data from 121 patients with wAMD (121 eyes) who were diagnosed by indirect ophthalmoscopy, fluorescence fundus angiography (FFA), indocyanine green angiography, and optical coherence tomography. Ranibizumab was injected into the vitreous cavities once per month for 3mo and as needed afterwards. Changes in visual acuity and central foveal thickness (CFT) during the follow-up period were compared, and the mean number of injections over the year was calculated. Patients with one or more adverse events related to the drugs and injections were recorded for further adverse events analysis. RESULTS: The study population included 70 males and 51 females aged between 50 and 87y (mean: 71.32±9.41y). The mean number of injections over the first year was 5±1 (range: 3-9). The mean best-corrected visual acuity by Early Treatment Diabetic Retinopathy Study increased from 43.2±19.3 (95%CI: 39.8-46.7) at baseline to 51.7±20.1 (95%CI: 48.1-55.3), and central foveal thickness (CFT) decreased from 526.5±277.0 µm (95%CI: 476.6-576.4) to 258.2±161.6 µm (95%CI: 229.2-287.3) at 12mo. The differences were statistically significant (P<0.001). Visual acuity significantly improved in 34.1% of the patients (38 eyes), stabilized in 66.1% of the patients (80 eyes), and significantly decreased in 2.5% of the patients (3 eyes). CFT at baseline was an independent risk factor of decreased CFT and increased visual acuity. None of the patients had severe adverse events during the follow-up period. CONCLUSION: Ranibizumab can effectively control disease progression and improve visual acuity in patients with wAMD. The disease conditions of most patients stabilized after a one-year treatment with an average of 5 injections.
AIM: To evaluate the clinical efficacy and safety of ranibizumab for wet age-related macular degeneration (wAMD) in Chinese patients and to determine the mean number of injections administered over one year of follow-up. METHODS: This single centre, retrospective observational case series study included data from 121 patients with wAMD (121 eyes) who were diagnosed by indirect ophthalmoscopy, fluorescence fundus angiography (FFA), indocyanine green angiography, and optical coherence tomography. Ranibizumab was injected into the vitreous cavities once per month for 3mo and as needed afterwards. Changes in visual acuity and central foveal thickness (CFT) during the follow-up period were compared, and the mean number of injections over the year was calculated. Patients with one or more adverse events related to the drugs and injections were recorded for further adverse events analysis. RESULTS: The study population included 70 males and 51 females aged between 50 and 87y (mean: 71.32±9.41y). The mean number of injections over the first year was 5±1 (range: 3-9). The mean best-corrected visual acuity by Early Treatment Diabetic Retinopathy Study increased from 43.2±19.3 (95%CI: 39.8-46.7) at baseline to 51.7±20.1 (95%CI: 48.1-55.3), and central foveal thickness (CFT) decreased from 526.5±277.0 µm (95%CI: 476.6-576.4) to 258.2±161.6 µm (95%CI: 229.2-287.3) at 12mo. The differences were statistically significant (P<0.001). Visual acuity significantly improved in 34.1% of the patients (38 eyes), stabilized in 66.1% of the patients (80 eyes), and significantly decreased in 2.5% of the patients (3 eyes). CFT at baseline was an independent risk factor of decreased CFT and increased visual acuity. None of the patients had severe adverse events during the follow-up period. CONCLUSION:Ranibizumab can effectively control disease progression and improve visual acuity in patients with wAMD. The disease conditions of most patients stabilized after a one-year treatment with an average of 5 injections.
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