Pieramici Dante J, Rabena Melvin, Castellarin Alessandro A, Nasir Ma'an, See Robert, Norton Tamara, Sanchez Andres, Risard Sarah, Avery Robert L
California Retina Consultants and Research Foundation, Santa Barbara, California 93103, USA.
Ophthalmology. 2008 Oct;115(10):e47-54. doi: 10.1016/j.ophtha.2008.06.021. Epub 2008 Aug 16.
Assessment of biological effect, visual acuity changes, and safety of intravitreal (IVT) ranibizumab in patients with macular edema associated with perfused central retinal vein occlusion (CRVO).
Ongoing, prospective, open-label, single-center, uncontrolled study.
Ten adult patients with macular edema associated with perfused CRVO.
Patients were randomly assigned to receive 3 monthly IVT injections of either 0.3 or 0.5 mg ranibizumab (n = 5 at each dose). Additional injections were administered quarterly as needed over the ensuing 21 months at the physician's discretion for recurrent or persistent macular edema.
The predetermined primary endpoint was the percentage of patients gaining >or=15 letters of best-corrected Early Treatment of Diabetic Retinopathy Study visual acuity (BCVA). The secondary endpoints include the mean change in BCVA and central retinal thickness (CRT) measured by optical coherence tomography, the rate of progression to ischemic CRVO, extent of intraocular hemorrhage, retinal vein diameter, optic nerve head swelling, and the incidence and severity of ocular and nonocular adverse events.
After 3, 6, and 9 months of follow-up, 40%, 10%, and 30% of patients, respectively, gained >or=15 letters in BCVA; mean BCVA improved by 12+/-20 letters, 3+/-21 letters, and 1+/-24 letters, respectively, compared with baseline; CRT showed a mean decrease of 272+/-244 microm, 88+/-178 microm, and 119+/-153 microm, compared with baseline. No significant differences were observed between the 0.3- and 0.5-mg doses. Most patients experienced decreases in the extent of retinal hemorrhage, retinal vein diameter, and optic nerve head swelling at months 3 and 6 compared with baseline. No patients progressed to ischemic CRVO or experienced a severe adverse event that was attributed to ranibizumab.
Ranibizumab is generally well-tolerated and may improve BCVA and decrease CRT. The improvements in BCVA and CRT observed during the initial monthly injection period (0 to 3 months) were possibly lost to the recurrence of macular edema in between ranibizumab injection during the quarterly treatments (3 to 9 months). The extent of retinal hemorrhage, retinal vein diameter, and nerve swelling continued to normalize for most of the patients from baseline to 6 months. Follow-up is ongoing, and alternative dosing regimens are being evaluated.
评估玻璃体内注射雷珠单抗治疗伴有灌注的视网膜中央静脉阻塞（CRVO）所致黄斑水肿患者的生物学效应、视力变化及安全性。
一项正在进行的前瞻性、开放标签、单中心、非对照研究。
10例伴有灌注的CRVO所致黄斑水肿的成年患者。
患者被随机分配接受每月1次、共3次玻璃体内注射0.3mg或0.5mg雷珠单抗（各剂量组n = 5）。在随后的21个月中，根据医生判断，视复发性或持续性黄斑水肿情况，必要时每季度追加注射。
预先设定的主要终点为最佳矫正视力（BCVA）提高≥15个字母的患者百分比。次要终点包括BCVA的平均变化、光学相干断层扫描测量的视网膜中央厚度（CRT）、进展为缺血性CRVO的发生率、眼内出血范围、视网膜静脉直径、视神经乳头水肿，以及眼部和非眼部不良事件的发生率和严重程度。
随访3、6和9个月时，分别有40%、10%和30%的患者BCVA提高≥15个字母；与基线相比，BCVA平均分别提高了12±20个字母、3±21个字母和1±24个字母；CRT与基线相比，平均分别降低了272±244μm、88±178μm和119±153μm。0.3mg和0.5mg剂量组之间未观察到显著差异。与基线相比，大多数患者在3个月和6个月时视网膜出血范围、视网膜静脉直径和视神经乳头水肿均减轻。无患者进展为缺血性CRVO或出现归因于雷珠单抗的严重不良事件。
雷珠单抗一般耐受性良好，可能改善BCVA并降低CRT。在最初每月注射期（0至3个月）观察到的BCVA和CRT改善，可能在季度治疗期间（3至9个月）雷珠单抗注射间隔期因黄斑水肿复发而消失。从基线到6个月，大多数患者的视网膜出血范围、视网膜静脉直径和神经水肿程度持续恢复正常。随访正在进行中，正在评估替代给药方案。
