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LUCENTIS TM (RANIBIZUMAB) INTRAVITREAL INJECTION

Lucentis TM (ranibizumab) injection is the newest wet age-related macular degeneration (AMD) treatment developed exclusively for use in the eye.
Lucentis TM has been FDA approved since July 2006 to maintain or improve vision in patients with wet AMD. This treatment is now available at Oklahoma Retina, PLLC and after examination Dr. Srouji will advice you if Lucentis TM is the best treatment option for you.

INDICATIONS:
Age-related macular degeneration (AMD) is the leading cause of blindness in people over 50 years of age. There are two types of macular degeneration: dry and wet. In the “wet” form of AMD, abnormal blood vessels grow in the back of the eye. Sometimes these vessels leak blood or fluid that causes blurred or distorted vision. Without treatment, vision loss may be quick and severe.

POSSIBLE BENEFITS, LIMITATIONS, AND ADMINISTRATION:
Lucentis TM works by inhibiting the growth of the abnormal blood vessels that cause AMD. It is also used to treat swelling of the macula due to AMD. The goal of treatment is to prevent further loss of vision. Although some patients have regained vision, the medication may not restore vision that has already been lost, and may not ultimately prevent further loss of vision caused by the disease.

After the pupil is dilated and the eye is numbed with anesthesia, the medication is injected into the vitreous, or jelly-like substance in the back chamber of the eye. Lucentis TM is administered by an injection into your eye as needed at regular intervals (about every four weeks); Dr. Srouji will tell you how often you will receive the injection, and for how long.

ALTERNATIVES:
You do not have to receive treatment for your condition, although without treatment, AMD can lead to further vision loss and blindness, sometimes very quickly. Other forms of treatment are available. At present, there are two other FDA-approved treatments for neovascular AMD: photodynamic therapy with a drug called Visudyne TM and injection into the eye of a drug called Macugen TM. Although both of these treatments have been proven to slow down the rate of visual loss, most people do not get back better vision. In addition to the FDA-approved medications, some ophthalmologists use other medications that were not specifically approved for use in the treatment of AMD, but which have shown some benefit. The two medications used this way are intravitreal Kenalog TM - a long-acting cortisone-like drug, and Avastin TM - a similar drug to Lucentis TM.

COMPLICATIONS FROM THE MEDICATION AND INJECTION:
Complications of Lucentis TM in other body parts -
A small number of patients (less than 4%) experienced blood clots (arterial
thromboembolic events such as heart attack or stroke) after administration of Lucentis TM. There is no evidence that Lucentis TM caused these complications. Whenever a medication is used in a large number of patients, a small number of coincidental life-threatening problems may occur that have no relationship to the treatment. For example, patients with diabetes are already at increased risk for heart attacks and strokes. If one of these patients being treated with Lucentis TM suffers a heart attack or stroke, it may be caused by the diabetes and not the Lucentis TM treatment.

Known risks of intravitreal eye injections -
Your condition may not get better or may become worse. Any or all of the following complications may cause decreased vision and/or have a possibility of causing blindness. Additional procedures may be needed to treat these complications. During the follow up visits or phone calls, you will be checked for possible side effects and the results will be discussed with you.

Possible complications of the procedure and administration of Lucentis TM include but are not limited to retinal detachment, cataract formation (clouding of the lens of the eye), glaucoma (increased pressure in the eye), hypotony (reduced pressure in the eye), damage to the retina or cornea (structures of the eye), and bleeding. There is also the possibility of an eye infection (endophthalmitis). You may receive eye drops with instructions on when to use them to reduce the possibility of this occurring. Any of these rare complications may lead to severe, permanent loss of vision. Side effects may include eye pain, subconjunctival hemorrhage (bloodshot eye), vitreous floaters, irregularity or swelling of the cornea, inflammation of the eye, and visual disturbances such as small specks in the vision.

PATIENT RESPONSIBILITIES:
Patient will be responsible to contact Dr. Srouji if any of the following signs of infection or other complications develop: pain, blurry or decreased vision, sensitivity to light, redness of the eye (compared to immediately after the injection), or discharge from the eye. Patient will be instructed NOT to rub eyes or swim for three days after each injection. Patient will be responsible to keep all post-injection appointments or scheduled telephone calls so Dr. Srouji can check for complications.

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AVASTIN TM (BEVACIZUMAB) INTRAVITREAL INJECTION

INDICATIONS:
Age-related macular degeneration (AMD) is the leading cause of blindness in people over 50 years of age. There are two types of macular degeneration: dry and wet. In the “wet” form of AMD, abnormal blood vessels grow in the back of the eye. Sometimes these vessels leak blood or fluid that causes blurred or distorted vision. Without treatment, vision loss may be quick and severe.

• There are other eye conditions that cause loss of vision due to abnormal growth of blood vessels in the back of the eye. These can occur even in young patients, and include, but are not limited to, conditions such as high myopia (nearsightedness), histoplasmosis, angioid streaks, and eye injury. Sometimes there is no known reason for the abnormal blood vessels. Without treatment, vision loss may be quick and severe.
  
• Refractory macular edema, or swelling around the macula, affects vision but does not respond adequately to the usual treatment methods. It can occur with conditions such as central retinal vein occlusion and diabetic retinopathy. Without effective treatment, vision loss could progress and become permanent.
  

POSSIBLE BENEFITS AND “OFF-LABEL” STATUS:
Avastin TM was not initially developed to treat your eye condition. Based upon the results of clinical trials that demonstrated its safety and effectiveness, Avastin TM was approved by the Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer. As a condition of approval, the manufacturer produced a “label” explaining the indications, risks, and benefits. The label explains that Avastin TM works by blocking a substance known as vascular endothelial growth factor or VEGF. Blocking or inhibiting VEGF helps prevent further growth of the blood vessels that the cancer needs to continue growing.

Once a device or medication is approved by the FDA, physicians may use it “off-label” for other purposes if they are well-informed about the product, base its use on firm scientific method and sound medical evidence, and maintain records of its use and effects. Ophthalmologists are using Avastin TM “off-label” to treat AMD and similar conditions since research indicates that VEGF is one of the causes for the growth of the abnormal vessels that cause these conditions. Some patients treated with Avastin TM had less fluid and more normal-appearing maculas, and their vision improved. Avastin TM is also used, therefore, to treat macular edema, or swelling of the macula.

POSSIBLE LIMITATIONS AND ADMINISTRATION:
The goal of treatment is to prevent further loss of vision. Although some patients have regained vision, the medication may not restore vision that has already been lost, and may not ultimately prevent further loss of vision caused by the disease. After the pupil is dilated and the eye is numbed with anesthesia, the medication is injected into the vitreous, or jelly-like substance in the back chamber of the eye. Avastin TM is administered by an injection into your eye as needed at regular intervals (about every four to six weeks); Dr. Srouji will tell you how often you will receive the injection, and for how long.

ALTERNATIVES:
You do not have to receive treatment for your condition, although without treatment, these diseases can lead to further vision loss and blindness, sometimes very quickly. Other forms of treatment are available. At present, there are three FDA-approved treatments for neovascular age-related macular degeneration: photodynamic therapy with a drug called Visudyne TM and injection into the eye of drugs called Macugen TM, and Lucentis TM. Although these treatments have been proven to slow down the rate of visual loss, most people do not get back better vision. Dr. Srouji will discuss with you the benefits and risks associated with these other choices of treatment. In addition to the FDA-approved medications, some ophthalmologists use intravitreal Kenalog TM - a long-acting cortisone-like drug - “off-label” to treat eye conditions like yours.

COMPLICATIONS AND RISKS:
Complications when Avastin TM is given to patients with cancer:
When Avastin TM is given to patients with metastatic colorectal cancer, some patients experienced serious and sometimes life-threatening complications, such as gastrointestinal perforations or wound healing complications, hemorrhage, arterial thromboembolic events (such as stroke or heart attack), hypertension, proteinuria, and congestive heart failure.

Patients who experienced these complications not only had metastatic colon cancer, but were also given 400 times the dose you will be given, at more frequent intervals, and in a way (through an intravenous infusion) that spread the drug throughout their bodies.

Risk when Avastin TM is given to treat patients with eye conditions:
Ophthalmologists believe that the risk of these complications for patients with eye conditions is low. Patients receiving Avastin TM for eye conditions are healthier than the cancer patients, and receive a significantly small dose, delivered only to the cavity of their eye. While there are no FDA-approved studies about the use of Avastin TM in the eye that prove it is safe and effective, there are ongoing clinical trials of a similar drug as well as studies of patients receiving Avastin TM “off-label.” One study of patients who received Avastin TM through an intravenous infusion reported only a mild elevation in blood pressure. Another study of patients treated like you will be with intravitreal Avastin TM (that is, Avastin TM injected into the eye) did not have these elevations or the other serious problems seen in the patients with cancer.

However, the benefits and risks of intravitreal Avastin TM for eye conditions are not yet fully known. In addition, whenever a medication is used in a large number of patients, a small number of coincidental life-threatening problems may occur that have no relationship to the treatment. For example, patients with diabetes are already at increased risk for heart attacks and strokes. If one of these patients being treated with Avastin TM suffers a heart attack or stroke, it may be caused by the diabetes and not the Avastin TM treatment.

Known Risks of Intravitreal Injections:
Your condition may not get better or may become worse. Any or all of these complications may cause decreased vision and/or have a possibility of causing blindness. Additional procedures may be needed to treat these complications. During the follow up visits or phone calls, you will be checked for possible side effects and the results will be discussed with you.

Any medication has the potential to cause allergic reactions in a small number of people. Symptoms of an allergic reaction can include a rash, hives, itching, shortness of breath, and rarely death. In general, allergic reactions to medicines are more likely to occur in people who have allergies to other drugs, foods, or things in the environment, such as dust or grass. If you have allergies to other medicines, foods, or other things in the environment, or if you have asthma, you should let your doctor know.

Possible complications and side effects of the procedure and administration of Avastin TM include but are not limited to retinal detachment, cataract formation (clouding of the lens of the eye), glaucoma (increased pressure in the eye), hypotony (reduced pressure in the eye), damage to the retina or cornea (structures of the eye), and bleeding. There is also the possibility of an eye infection (endophthalmitis). You may receive eye drops with instructions on when to use them to reduce the possibility of this occurring. Any of these rare complications may lead to severe, permanent loss of vision.

Patients receiving an injection of Avastin TM may experience less severe side effects related to the pre-injection preparation procedure (eyelid speculum, anesthetic drops, dilating drops, antibiotic drops, povidone-iodine drops and the injection of the anesthetic). These side effects may include eye pain, subconjunctival hemorrhage (bloodshot eye), vitreous floaters, irregularity or swelling of the cornea, inflammation of the eye, and visual disturbances.

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MACUGEN
PEGAPTANIB SODIUM INJECTION

* What is Macugen?

Macugen is the first therapy approved by the US Food and Drug Administration to treat all types of wet macular degeneration. Macugen is available by prescription only.

* How does Macugen work?

Macugen works differently from all other treatments. Macugen blocks a key signal that causes abnormal vessels to grow and leak. By helping to slow the growth of these abnormal blood vessels, Macugen can slow the damage they do to your sight.

The goal of therapy with Macugen is to help slow the progression of your disease and preserve your vision. In clinical trials, patients receiving Macugen lost less vision on average than patients who did not receive Macugen. However, results may vary from person to person.

* What to expect when receiving therapy with Macugen:

Macugen is a medicine that is injected into the eye and is given by your doctor in the office every 6 weeks. The medicine is delivered by injection to reach the back of the eye where it is needed. Dr. Srouji is trained in treating eye diseases and in giving eye injections. During your treatment, there are steps that Dr. Srouji will follow such as numbing the surface of your eye. In clinical studies, the vast majority of people kept receiving their injections of Macugen. If you have specific questions about Macugen or the injection procedure, please call our office at (405) 945-4848.

* What are the side effects?

With Macugen, you may feel some side effects, mostly in the eye and due to the injection procedure. The most common side effects are burning sensation, eye pain, redness, light sensitivity, vision loss, blurred vision, visual disturbances, and cataract. For a complete list of side effects, please ask Dr. Srouji, or see the prescribing information.

You should not receive Macugen if you have an infection in or around your eye

* Contact our office. immediately if you have unusual symptoms after your injection:

A serious eye infection can sometimes develop after an injection into the eye. Signs of a serious infection may include eye pain, light sensitivity, and/or vision changes. Check with Dr. Srouji immediately if you experience any of these symptoms, so you can be treated early if an infection occurs.

Eye injections like those with Macugen can increase eye pressure. This is something you would not notice1 however, Dr. Srouji may do some extra tests after your injection to make sure there are no complications.

* For best results make a commitment to therapy with Macugen:

Wet macular degeneration is a disease that should be treated with a sense of urgency. It’s a chronic disease, which means it’s important to get regular treatment over time. Getting treatment early and keeping up with your regimen are essential to help preserve as much of your vision as possible.

In clinical studies, people received Macugen every 6 weeks. Continuing regular treatment with Macugen is important to obtain maximum benefit. Please follow your doctor’s recommendations for your therapy.

Macugen cannot fully stop the disease, but it can slow the growth of abnormal blood vessels, thus slowing the damage to your sight. Not all people respond the same to Macugen, so individual results may vary.

Protecting your vision may help you maintain your independence, so it’s important to follow your doctor’s recommendations for therapy. Your vision is worth it.

* Make a commitment to working with Dr. Srouji:

Dr. Srouji is your best partner in protecting your vision. He can help you take control of your disease early, so you can keep the vision you have as long as possible.

Wet macular degeneration is a chronic disease that requires regular treatment, so it’s important to commit to your treatment schedule. The longer you go without treatment, the more vision you may lose.

If you have any questions about how Macugen works or what to expect during treatment, check with Dr. Srouji.

Be sure to stay in touch with our office so Dr. Srouji can keep track of your disease. To do this, you may be tested with an eye chart, a simple tool called the Amsler grid, or tests called fluorescein angiography (FA) and optical coherence tomography (OCT) that let your doctor view the back of your eye.

Since wet macular degeneration can quickly lead to lasting eye damage, always check with Dr. Srouji right away if you notice any changes in your vision.

Copyright 2005 (OSI) Eyetech Pharmaceuticals, Inc. and Pfizer Inc.
All rights reserved
MACUGEN®

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