PHILADELPHIA, Pa. (Ivanhoe Newswire) - Diabetes affects 26 million people in the U.S. and is the leading cause of new blindness in adults. Now for the first time in a long time, the FDA has approved a drug to help save diabetics' vision.
Tax accountant John Dunn has had diabetes for 20 years but he had no idea it was hurting his eyes.
"I was having a lot of headaches and I thought it was the stress of tax season," Dunn told Ivanhoe.
A routine eye exam showed he had diabetic macular edema, or DME.
"I think I could have lost my vision," Dunn said.
Instead, Doctor Allen Ho was able to save John's sight with Lucentis, a drug used for years to treat macular degeneration that was just FDA approved for DME.
"It's the first new treatment for patients with diabetes and diabetic macular edema in 25 years," Allen Ho, M.D., Wills Eye Hospital Retina Service, Director of Retina Research, Mid Atlantic Retina, Professor of Ophthalmology at Thomas Jefferson University, said.
Traditional laser treatments focused on stopping a patient's sight from getting worse but couldn't restore vision. Doctor Ho said Lucentis can.
"This drug is really a miracle drug," Dr. Ho said.
It's injected directly into the patient's eyes.
"It usually feels like a little pinch. Patients are nice and numb, and the patient will often come off it and say did you do the injection yet? They often can't feel it." Dr. Ho told Ivanhoe.
The injections have restored John's vision to almost 20/20.
Now he's grateful for the gift of sight and focused on managing his diabetes.
Doctor Ho said far too many diabetes patients have no idea that diabetes can affect the eyes. He recommends diabetics get an eye exam at least once a year, whether they are having vision problems or not.
BACKGROUND: Diabetic eye disease refers to a group of eye problems that people with diabetes may face as a complication of diabetes. All can cause severe vision loss or even blindness. Diabetic eye disease may include: Diabetic retinopathy—damage to the blood vessels in the retina; Cataract—clouding of the eye's lens. Cataracts develop at an earlier age in people with diabetes; Glaucoma—increase in fluid pressure inside the eye that leads to optic nerve damage and loss of vision. A person with diabetes is nearly twice as likely to get glaucoma as other adults. Diabetic retinopathy is the most common diabetic eye disease and a leading cause of blindness in American adults. It is caused by changes in the blood vessels of the retina. In some people with diabetic retinopathy, blood vessels may swell and leak fluid. In other people, abnormal new blood vessels grow on the surface of the retina. The retina is the light-sensitive tissue at the back of the eye. A healthy retina is necessary for good vision. If you have diabetic retinopathy, at first you may not notice changes to your vision. But over time, diabetic retinopathy can get worse and cause vision loss. Diabetic retinopathy usually affects both eyes. (Source: healthproblems101.com)
SIGNS: Often there are no symptoms in the early stages of the disease, nor is there any pain. Don't wait for symptoms. Be sure to have a comprehensive dilated eye exam at least once a year. Blurred vision may occur when the macula—the part of the retina that provides sharp central vision—swells from leaking fluid. This condition is called macular edema. If new blood vessels grow on the surface of the retina, they can bleed into the eye and block vision. At first, you will see a few specks of blood, or spots, "floating" in your vision. If spots occur, see your eye care professional as soon as possible. You may need treatment before more serious bleeding occurs. Hemorrhages tend to happen more than once, often during sleep. Sometimes, without treatment, the spots clear, and you will see better. However, bleeding can reoccur and cause severely blurred vision. You need to be examined by your eye care professional at the first sign of blurred vision, before more bleeding occurs. If left untreated, proliferative retinopathy can cause severe vision loss and even blindness. Also, the earlier you receive treatment, the more likely treatment will be effective. (Source: http://www.nei.nih.gov)
TREATMENT: During the first three stages of diabetic retinopathy, no treatment is needed, unless you have macular edema. To prevent progression of diabetic retinopathy, people with diabetes should control their levels of blood sugar, blood pressure, and blood cholesterol. Proliferative retinopathy is treated with laser surgery. This procedure is called scatter laser treatment. Scatter laser treatment helps to shrink the abnormal blood vessels. Your doctor places 1,000 to 2,000 laser burns in the areas of the retina away from the macula, causing the abnormal blood vessels to shrink. Because a high number of laser burns are necessary, two or more sessions usually are required to complete treatment. Although you may notice some loss of your side vision, scatter laser treatment can save the rest of your sight. Scatter laser treatment may slightly reduce your color vision and night vision. Scatter laser treatment works better before the fragile, new blood vessels have started to bleed. That is why it is important to have regular, comprehensive dilated eye exams. Even if bleeding has started, scatter laser treatment may still be possible, depending on the amount of bleeding. If the bleeding is severe, you may need a surgical procedure called a vitrectomy. During a vitrectomy, blood is removed from the center of your eye. (Source: http://www.nei.nih.gov)
NEW TECHNOLOGY: The FDA has just approved of a new drug called Lucentis that has shown to save diabetics' vision. The drug is injected into patients eyes, but patients often don't even feel it. Commonly reported side effects of Lucentis include bleeding of the eye's conjunctiva tissue, eye pain, floaters and increased pressure inside the eye. Lucentis, marketed by San Francisco-based Genentech, was approved previously for wet age-related macular degeneration, and another form of macular edema.
Dr. Allen Ho, Professor of Ophthalmology at Thomas Jefferson University, Mid Atlantic Retina and Director of Retina Research at Wills Eye Hospital, talks about a new drug helping to save diabetes patients' eyesight.
Can you talk about Lucentis?
Dr. Ho: The new drug for patients with vision loss from diabetes mellinus is known as Ranibizumab or Lucentis. Lucentis is a drug that's injected into the eye to try and reduce leakage associated with swelling in the macula or the focus point in the eye, and this drug has previously been shown to be effective for patients with wet macular degeneration, and now is approved for patients with diabetic leakage as well. It's the first new treatment for patients with diabetes and diabetic macular edema in 25 years. It can take someone who has some loss of vision and actually give them a reasonable chance at improvement in vision over time. All our other therapies have typically been stabilization or preventing the vision from getting worse. It was just approved last week by the FDA.
What other traditional therapies are there right now?
Dr. Ho: The traditional therapy is laser treatment, which has been our standard treatment for the past 25 or 35 years. These new injections have come into play since about 2005 for patients with macular edema, for patients with vein inclusions or mini strokes in the eye, and now for this large population of patients with diabetes and diabetic macular edema.
Is this going to improve vision for diabetics?
Dr. Ho: All patients should get her eyes examined if they have diabetes, whether or not they're having vision problems. At least an annual eye exam is a minimum. If we can get to the patients early and they do have problems, yes, in many cases we can create improvement in vision.
Do patients know it can be treated?
Dr. Ho: We do have treatments, but patients aren't coming in to get checked for preventive measures or for treatment. They're losing vision when there's something out there that can treat them and benefit them.
How do the injections work?
Dr. Ho: Well, it usually feels like a little pinch; patients are nice and numb and patients will come off and say did you do the injection yet? They often can't feel it. So I don't want to trivialize any injection into the eye, but really we do it very often and we're very good at it for those that do a lot of injections and patients can tolerate it very well. Our current standard of care injections deliver biologic medicines or steroid medicines to the retina that reduce abnormal blood vessel growth and leakage that can lead to vision loss. On label ranibizumab (Lucentis, Genentech) and off label bevacizumab (Avastin, Genentech) are the leading biologic medicines for diabetic retinopathy and they inhibit a factor known as Vascular Endothelial Growth Factor (VEGF).
How often do you need to have an injection done to them?
Dr. Ho: Some patients need to have injections as frequently as monthly, other patients can go for longer intervals. It depends on the particular patient. After an injection, patients can be blurry for a couple hours but generally they are doing fine shortly thereafter.
Is this a game changer?
Dr. Ho: Yes, Lucentis is really a miracle drug. It's really transformed two of the leading causes of blindness in our country. Number one - wet age related macular degeneration; it's taken that condition where we had no treatments that were able to improve vision and now we are able to improve vision in so many patients. For a grandparent that wants to read a book, see their grandchildren, or drive a car it's completely transformed the quality of life of an entire generation of patients. Another leading cause of blindness in younger adults is diabetes, and now this drug is approved for the treatment of the most common mechanism of vision loss from diabetes; that is macular edema or swelling. It's really transforming therapy. It's breakthrough therapy and it's very important for all of these patients with diabetes mellitus.
What about with John, can you tell me what you are able to do for him?
Dr. Ho: John's story is probably one of the more gratifying stories in the patients that I've had in my practice. John was the guy who is diabetic and who admittedly was not taking care of himself. Patients with diabetes can feel like they're losing control; my sugar's out-of-control, maybe I'm gaining weight, I'm not exercising, I don't feel good. Well, he completely turned the tables and he's an example of how important it is to take care of yourself and then everything else follows. Specifically, he changed his diet. It's hard to go down to a half portion, maybe you can reduce it by a third, maybe you can get rid of the white pasta and go whole-grain pasta, maybe you can stop snacking at night, or like another patient stopped drinking sodas. You can lose weight, particularly if you combine it with some regular physical activity that is good for your heart, good for your body, good for your blood sugar and your blood pressure. He came in motivated and was already turning things around for himself and feeling better, but he had loss of vision from the diabetic macular edema. We started injections; we were doing these injections before the FDA approval. He's now at almost 20/20 vision from vision that was not going to allow him to drive a car. John's a very bright productive young executive and it was a great example of transforming. Most importantly, he feels like he has control now. The message to patients with diabetes is that you can do it, you can transform things. It takes little steps at a time to finally get the positive cycle and positive energy going.
Was he part of the trial?
Dr. Ho: He was not part of the trial, but he was getting treatments prior to the approval for this indication. He has been getting these types of injections.
Does he still have to come back to get them?
Dr. Ho: He still comes back for monitoring. Sometimes patients don't need injections indefinitely. Sometimes you can have some laser treatments, reduce the number of injections, and he's done very well that way.
Does he have macular degeneration?
Dr. Ho: No, he has diabetic macular edema.
How is our health linked to our eyes?
Dr. Ho: They say that the eyes are the window to your soul, but they are also the windows to your health. The reason for that is you can look through the eyes and look to the back of the eye, for example the retina, and see changes from diabetes because you can see the blood vessels since you can see through the eye. We can see changes from high blood pressure, we see changes from diabetes, and we can sometimes tell if patient's cholesterols are too high. There are a lot of different things that the eyes can do that reflect general health. So getting a regular eye exam is really important. Even if you're seeing well just getting checked is very important.
What signs should people be looking for?
Dr. Ho: Important signs and symptoms that should be evaluated: certainly, any sudden loss of vision, even if it's transient loss of vision where you lose vision and then you gain your vision back. You want to know what that's from and it can be a variety of things that are dangerous to your eyes and to your body. Certainly red eyes and eyes that are in pain all need to be evaluated well. It could be something as simple as pinkeye or it could be something in your eye.Another example of how the eyes can reflect general body health is if your eyes are bulging, that may be a sign of thyroid problems. Graves' disease can be reflected by swelling of the muscles of the eyes and the eyes therefore bulge. The retina is really the classic place to look for changes from high blood pressure; we can give you some images of that. Diabetic eye disease, we can also give you some images of that. Sometimes swelling in the brain or high pressure in the brain can be reflected in swelling of the nerves in the eyes. The eyes are really an extension of the brain. Those are some of the things that we see that reflect general disease. Chronic redness in one eye always brings to mind some peculiar things, like brain fistulas. Of course infections, pinkeye, or allergic reactions are the most common reasons for redness and itching in the eye.
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