诺华公司（Novartis）公布了新药Ranibizumab III期临床研究的初步结果显示，对于治疗糖尿病导致的视网膜水肿（diabetic macular edema，DME），Ranibizumab比现在通用的激光治疗更加有效。来自德国乌尔姆大学（Ulm）视网膜激光手术外科负责人Gabriele Lang在欧洲糖尿病眼病并发症研讨会（Diabetic Eye Complications，EASDec)上发表了此项期临床研究结果。

Ranibizumab商标名为Lucentis，在80多个国家被批准用于治疗与年龄相关性视力减退(age-related macular degeneration，AMD)病症。但是目前Ranibizumab尚未获得治疗DME的销售许可证，为此，诺华公司曾在2009年12月向欧盟卫生当局（EU health authorities）递交市场销售许可申请。

Novartis表示，在为期1年临床试验中，只服用0.5mg Ranibizumab的患者有37%达到视力提高10个或更多字母，而如果服用0.5mg Ranibizumab的同时采取激光治疗，则有43%的患者可以达到，相比之下，仅仅采用激光治疗的数据仅为16%。临床试验1年后，同时配以Ranibizumab 和激光治疗的患者视力提高5.9个字母，只采用Ranibizumab药物治疗的则提高6.1个字母，然而只采取激光治疗的视力矫正仅为0.8个字母。采用Ranibizumab来提高视觉灵敏度不仅所需时间短，而且效果持久。

美国一项调查结果也证明了Ranibizumab的药效，这些实验依据为获得欧盟卫生局的批准奠定了基础。

Ranibizumab不仅可用于治疗AMD，也可用于治疗DME，Ranibizumab是一种特别设计的新药，为治疗糖尿病性黄斑水肿病人提供了一种新的治疗选择。

Lucentis

Generic name: Ranibizumab

What is Lucentis?

Lucentis is used to treat neovascular (wet), age-related macular degeneration. Wet AMD causes vision loss in your central field of vision.

What is the most important information I should know about Lucentis?

Injections into the eye, such as Lucentis, may cause an inflammation of the tissues in the eye, or detachment of your retina. Also, increases in eye pressure have been seen within 1 hour of receiving Lucentis. Although rare, conditions associated with eye- and non-eye-related blood clots may occur. If your eyes become red, sensitive to light, painful, or you develop a change in vision in the days following Lucentis administration, seek care from your eye doctor immediately.

Who should not take Lucentis?

Do not take Lucentis if you have an eye infection or if you are allergic to one of its ingredients.

What should I tell my doctor before I take the first dose of Lucentis?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Lucentis. Also, talk to your doctor about your complete medical history, especially if you are experiencing an eye infection. Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: Lucentis 0.5 milligrams (mg) (0.05 milliliters [mL]) is recommended to be given once a month (approximately every 28 days). Although it may be less effective, treatment may be reduced to 1 injection every 3 months after the first 4 injections.

How should I take Lucentis?

Lucentis will be injected into your eye once a month by your doctor. Following the injection of Lucentis, you should be monitored for increases in eye pressure and inflammation of the tissues in the eye.

What should I avoid while taking Lucentis?

Avoid activities that may cause sensitivity to your eye or change the condition of your eye. Avoid continued use of Lucentis if the condition of your eye changes or worsens and notify your doctor immediately.

What are possible food and drug interactions associated with Lucentis?

No significant interactions have been reported with Lucentis at this time. However, always tell your doctor about any medicines you take, including over-the-counter drugs, vitamins, and herbal supplements.

What are the possible side effects of Lucentis?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: achy joints, anxiety, back pain, bleeding in the eye, bronchitis, cataracts, constipation, cough, dizziness, detached retina, difficulty breathing, dry eye(s), eye irritation, eye pain, flulike symptoms, headache, increased cholesterol, increased eye pressure, increased tears, inflammation of the eye or eyelid, inflammation of the nose and throat, insomnia, itchy eye(s), nausea, pain in an extremity, increased blood pressure, sinus infection, upper respiratory tract infection, urinary tract infection, vitreous "floaters"

Can I receive Lucentis if I am pregnant or breastfeeding?

The effects of Lucentis during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding.

What should I do if I miss a dose of Lucentis?

If for some reason you cannot make monthly appointments for Lucentis injections, talk to your doctor about reducing the frequency of injections from monthly to every 3 months. This can only happen after the first 4 injections have been given on a monthly basis.

How should I store Lucentis?

Store in a refrigerator; do not freeze. Protect vials from light and store them in the original carton until the time of use.

DRY & WET MACULAR DEGENERATION:
The dry form (non-exudative AMD) which accounts for the majority of cases of AMD is slowly progressive. Unfortunately, patients with dry AMD may progress to the more rapidly progressive wet AMD and ultimately experience rapid loss of central vision leading to legal blindness.

HARDENING OF THE ARTERIES IN THE EYE:
Simply speaking, macular degeneration is hardening of the arteries (arterio-sclerosis) in the eye. The same basic aging process that causes heart disease, peripheral vascular disease, carotid disease and cerebral vascular disease causes macular degeneration.

The same fundamental process that causes heart attacks and strokes can also cause blindness from macular degeneration. Bad circulation in the heart can cause a coronary thrombosis (heart attack); bad circulation in the brain can cause a cerebral thrombosis (stroke); bad circulation in the neck can also cause strokes; bad circulation in the legs can result in amputation; and bad circulation in the eye can cause blindness from macular degeneration. Patients with any of these age-related circulatory conditions are prone to developing other circulation problems. As a result, heart attack and stroke patients should also be concerned about their eyes.

THE CAUSE OF THE VISION LOSS:
After blood flow has been interrupted by a blood clot or blockage due to bad circulation, the body inappropriately responds to this injury by producing abnormal blood vessels. These abnormal blood vessels (choroidal neo-vascularization) are not “healthy”. They are extremely fragile and leak fluid and blood into the delicate retinal tissues. This results in irreversible damage to the retinal tissues, which are now denied their normal healthy blood flow and nutrition. It is these delicate retinal nerve fibers that transmit the visual signals to the brain. As such, any damage to these tissues caused by the interruption of normal circulation will result in irreversible loss of vision in this area. Unfortunately this damage most commonly occurs in the very center or the retina called the macula, and results in the loss of central vision. It is our central vision that allows us to read, watch TV, play bingo, see our computer, etc. Although the macula represents less than 5% of our entire retina, it accounts for more than 95% of the visual function (e.g., reading, writing, computer, TV, driving etc.).

PAST TREATMENT OPTIONS:
Argon Laser:
In the past, all that could be done to treat the abnormal blood vessels that developed in macular degeneration was to destroy them with the Argon laser. Although this treatment was able to stop the spreading growth of the abnormal blood vessels, of necessity, it also had to destroy the never fibers in the area. As a result, in order to retard the progression of the disease, the Argon treatment also resulted in damage to the retina. Vision therefore was not improved.

Visudyne:
About four years ago, photodynamic therapy (PDT) using an injectable material called Visudyne was introduced to treat the leaking blood vessels of wet macular degeneration. The Visudyne was injected into the patient’s veins and as it circulated through the retina, the doctor would use a laser to “zap” the laser-sensitive molecule as it passed through the leaky blood vessels. This was more precise than the Argon laser because it only treated the areas of bad circulation and therefore was much gentler on the retinal nerve fibers. PDT however required multiple re-treatments and was still a “destructive” procedure. More importantly it did not get to the underlying mechanism of the progression of AMD, i.e., the growth of abnormal blood vessels. Something was needed that could retard the growth of abnormal vessels without causing localized damage to surrounding tissues. Something was needed to get at the underlying mechanism of abnormal blood vessel proliferation.

Lucentis:
The answer to preventing the spread of abnormal leaky blood vessels following strokes, heart attacks and wet macular degeneration would not come from the circulation doctors or the retinal doctors, but from the cancer doctors. They had discovered that tumors grew rapidly because of a compound they named “vascular endothelial growth factor (VEGF)”. They next developed medicines that could destroy VEGF, thereby halting the expansion and growth of the tumors. Basic scientists soon recognized the potential of this new class of medicines in the treatment of the circulatory disease associated with the same rapid growth of bad blood vessels seen in tumor growth. Now there was a way to get at the fundamental cause of vascular growth after strokes, including the growth of blood vessels characteristic of wet macular degeneration. Lucentis is the “descendent” of these cancer treatment medications and has been adapted specifically for use in the eye.

HOW IS AMD DIAGNOSED?
Macular degeneration can only be diagnosed effectively by dilating the pupil of the eye and examining the retina. If suspicious areas are identified, they are studied more carefully with tests like Fluorescein Angiography and computer imaging. Fluorescein Angiography is an angiogram of the eye and is totally analogous to a coronary angiogram which is performed to evaluate heart circulation prior to angioplasty or by-pass surgery. If these tests show “active” abnormal retinal circulation, then Lucentis is possible.

HOW IS LUCENTIS TREATMENT PERFORMED?
The eyeball is numbed with an anesthetic (Xylocane) placed on a simple sterile Q-tip and held on the eye for a few seconds. Once numb, a small amount of Lucentis is introduced by injection into the vitreous of the eye. That’s it! There is virtually no pain. Not only can this small injection slow-down and ultimately stop the expansion of the abnormal circulation, it can actually reverse damaged nerve tissue if it is done in time.

FOLLOW-UP
Since the damage following the growth of abnormal retinal blood vessels (wet macular degeneration) can be progressive, close follow-up is necessary. Repeat Fluorescein Angiograms, computer imaging and repeat Lucentis treatments are necessary until the damage has been corrected.