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2012年8月10日美国食品和药品监督管理局(FDA)批准Lucentis(ranibizumab注射剂)为治疗糖尿病黄斑水肿(DME)，在患糖尿病人们中发生的一种轻微威胁眼疾病。
由卫生保健人员注射给予一次注射，Lucentis时意向与良好糖尿病血糖控制一起使用。
DME是一种情况其中液体漏入黄斑，发生尖锐，直前方的视野网膜的中央部分视力。液体式黄斑膨胀，引起视力模糊。
按照 美国疾病控制和预防中心，糖尿病(1型和2型)在美国影响约26百万人和是年龄20至74岁人中新失明的领先原因。在2010，报道3.9百万成年被诊断有糖尿病与其视力问题。
FDA的药物评价和研究中心移植和眼科产品室主任Renata Albrecht，M.D. 说“糖尿病是美国重大的公共卫生问题，而所有糖尿病患者处在发生糖尿病黄斑水肿的风险，”“今天的批准代表视力受DME损伤作为其疾病合并症人们治疗的重大发展。”
在两项临床研究药物治疗涉及759例患者被治疗和随访三年确定DME的安全性和有效性。研究的头24个月期间患者被随机赋予接受每月Lucentis注射0.3 mg或0.5 mg，或无注射。在24个月后，所有患者每个月接收Lucentis或 0.3 mg或0.5 mg.。
当在视力表上测量视力增加的患者数。结果显示用每个月Lucentis 0.3 mg视力增加至少三行占34%和45% 间与之比较为接收治疗患者为12%至18%。每月较高剂量0.5 mg 的Lucentis 没有观察到增加效益。
用Lucentis治疗患者中报道最常见副作用包括结膜出血，眼睑内侧线和覆盖眼睛白色部分的组织；眼痛；飞蚊症；和眼内压增加。
生长和漏液体入黄斑。Lucentis还被批准治疗网膜静脉闭塞后黄斑水肿，a of the 小静脉的阻断携带血液从网膜流出可引起液体漏入黄斑。
Lucentis由旧金山Calif.-基于加州Genentech公司上市.
完整处方资料：http://www.gene.com/gene/products/information/pdf/lucentis-prescribing.pdf
处方资料重点
这些重点不包括安全和有效使用LUCENTIS所需所有资料。请参阅下文为LUCENTIS的完整处方资料
LUCENTIS(ranibizumab injection)
玻璃体内注射
美国初次批准：2006
最近重大修改
（1）适应证和用途，糖尿病黄斑水肿(DME) (1.3) 08/2012
（2）剂量和给药方法，糖尿病黄斑水肿(DME) (2.4) 08/2012
（3）剂量和给药方法，给药 (2.6) 08/2012
（4）警告和注意事项，眼内炎和视网膜脱离(5.1) 08/2012
（5）警告和注意事项，眼内压增加(5.2) 08/2012
（6）警告和注意事项，血栓栓塞事件(5.3) 08/2012
（7）警告和注意事项，DME患者中致命性事件(5.4) 08/2012
适应证和用途
LUCENTIS适用于治疗以下患者：
（1）新生血管(湿)年龄相关黄斑退行性变性(AMD) (1.1)
（2）视网膜血管闭塞(RVO)后黄斑水肿(1.2)
（3）糖尿病黄斑水肿(DME) (1.3)
剂量和给药方法
只为眼科玻璃体内注射 (2.1)
新生血管(湿)年龄相关黄斑退行性变性(AMD) (2.2)
（1）建议通过玻璃体内注射1个月1次(约28天)LUCENTIS 0.5 mg (0.05 mL)给予。
（2）尽管疗效较低，如果每月注射不可行，在头4次注射后治疗可减低至每3个月1次注射。与每3个月给药比较，每3个月给药将导致在9个月后平均丧失视力效益接近5-字母(1行)。应常规治疗患者。
视网膜血管闭塞(RVO)后黄斑水肿(2.3)
（1）建议玻璃体内注射1个月1次(约28天)LUCENTIS 0.5 mg(0.05 mL)给药。在RVO临床研究中，患者每月接收LUCENTIS注射共6个月。尽管正是通过光学相干断层扫描[optical coherence tomography]和视力再-治疗标准，据经验患者然后在平均第6个月不治疗，而患者在第6个月不治疗在第7月丧失视力。患者应每个月被治疗。
糖尿病黄斑水肿(DME) (2.4)
（1）建议玻璃体内注射1个月1次(约28天)LUCENTIS 0.3 mg (0.05 mL)给药。
剂型和规格
（1）10 mg/mL溶液(LUCENTIS 0.5 mg) (3)
（2）6 mg/mL溶液(LUCENTIS 0.3 mg) (3)
禁忌证
（1）眼或眼周围感染 (4.1)
（2）超敏性(4.2)
警告和注意事项
（1）玻璃体内注射后可能发生眼内炎和视网膜脱离。注射后应监视患者 (5.1).
（2）玻璃体内注射前和后均曾注意到眼内压增加(IOP)。(5.2).
（3）使用VEGF抑制剂玻璃体后有动脉血栓栓塞事件潜在风险。(5.3).
（4）在DME每个月用LUCENTIS治疗患者比对照组更频繁发生致命性事件。(5.4).
不良反应
（1）最常见不良反应(LUCENTIS-治疗受试者比对照受试者报道更频繁)是结膜出血，眼痛，玻璃体飞蚊症，和IOP增加 (6.2).
为报告怀疑不良反应，联系Genentech电话1-888-835-2555或FDA电话1-800-FDA-1088或www.fda.gov/medwatch 。
处方更新日期：08/2012
Lucentis Approved for Treatment of Diabetic Macular Edema (DME)
On August 10, 2012, Lucentis® (ranibizumab injection) was approved for the treatment of diabetic macular edema (DME), an eye condition that causes blurred vision, severe vision loss and sometimes blindness. Diabetes is now the leading cause of new cases of blindness in working-aged Americans, and DME is estimated to affect more than 560,000 people with diabetes.
Lucentis is only FDA-approved medicine shown to rapidly and significantly improve vision loss from DME and is the first major treatment advancement for the disease in more than 25 years. More patients who received Lucentis 0.3mg were able to read at least three additional lines (15 letters) on the eye chart after 24 months of treatment: RIDE: 34 percent, 0.3 mg versus 12 percent, control; RISE: 45 percent, 0.3 mg versus 18.1 percent, control (primary endpoint).
Important Safety Information
Lucentis is a prescription medication given by injection into the eye, and it has side effects. Lucentis is not for everyone. You should not use Lucentis if you have an infection in or around the eye or are allergic to Lucentis or any of its ingredients.
Some Lucentis patients have serious side effects related to the injection. These include serious infections inside the eye, detached retinas, and cataracts. Other uncommon serious side effects include inflammation inside the eye and increased eye pressure. These side effects can make your vision worse. Some patients have had increased eye pressure within 1 hour of an injection. Your eye doctor should check your eye pressure and eye health during the week after your Lucentis injection.
Uncommonly, Lucentis patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes.
If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your eye doctor right away.
The most common eye-related side effects are increased redness in the white of the eye, eye pain, small specks in vision, and increased eye pressure. The most common nonÐeye-related side effects are nose and throat infections, headache, lung/airway infections, and nausea.
Who is LUCENTIS for?
LUCENTIS® (ranibizumab injection) is a prescription medicine for the treatment of patients with wet age-related macular degeneration (wet AMD).
What important safety information should I know about LUCENTIS?
LUCENTIS is a prescription medication given by injection into the eye, and it has side effects. Some LUCENTIS patients have had detached retinas and serious infections inside the eye. You should not use LUCENTIS if you have an infection in or around the eye or are allergic to LUCENTIS or any of its ingredients.
Uncommonly, LUCENTIS patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes.
Some patients have had increased eye pressure within 1 hour of an injection.
Serious side effects include inflammation inside the eye and, rarely, problems related to the injection procedure, such as cataracts. These side effects can make your vision worse.
The most common eye-related side effects are increased redness in the white of the eye, eye pain, small specks in vision, and increased eye pressure. The most common non–eye-related side effects are nose and throat infections, headache, joint pain, and lung/airway infections.
If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your eye doctor right away.
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