Posted on 08/06/2006 7:07:14 AM PDT by Dark Skies
Marion Kleinfeld got up one Sunday morning, picked up the newspaper, settled down to read it, and couldn't see the words.
Kleinfeld, 79, of Delray Beach, Fla., already blind in her right eye, lost sight in her other eye because of a condition called wet age-related macular degeneration, AMD, the leading cause of blindness in people over 55. Leaking blood vessels in the back of the eye cause a large black spot in the center of vision.
"I could not see at all. It was very frightening," she said.
After years of having to tell patients losing their eyesight to wet AMD that nothing could be done, doctors now can offer hope. On June 30, the U.S. Food and Drug Administration approved Lucentis to treat wet AMD, which strikes an estimated 155,000 people a year. The approval came seven years after the drug's maker, Genentech Inc., began the first test in humans, said Dawn Kalmar, a spokesperson for the company based in San Francisco.
About 95 percent of patients regain their sight after treatment, and in some, vision gradually gets better than it was before the onset of the disease.
When Kleinfeld's first eye developed the condition several years ago there was no treatment. But this time as soon as she got to retina specialist Mark Michels' office in South Florida, she got an injection that restored her vision.
"Within a week I could see again, and by the end of the month, I was seeing perfect," she said. "It was amazing how quick it happened."
Genentech makes another drug, Avastin, which retina specialists have discovered may work just as well as Lucentis and costs much less. It is approved by the FDA to treat cancer by stopping formation of blood vessels around tumors, but doctors can use it "off-label" to stop the leaking blood vessels at the back of the eye.
Lucentis, which is covered by Medicare, costs about $2,000 for one eye injection each month; Avastin costs $17 to $50 a month for one injection.
Kleinfeld got her treatment as part of a clinical trial of Lucentis, a biological drug that blocks a protein, VEGF, which causes abnormal blood vessel growth. She continued to get injections in her left eye once a month for 24 months as part of the study. She said the injections were not painful. Now she goes about every three months.
Clinical trials are continuing in South Florida and other locations to determine how many treatments should be given and how often.
"It's just a gift from God as far as I'm concerned," Kleinfeld said. "I can see my grandchildren. I have five beautiful grandchildren."
Dr. Philip Rosenfeld, professor of ophthalmology at the University of Miami Miller School of Medicine, said he initially tried Avastin in patients who were going blind and who were not being helped by earlier drugs approved to treat wet AMD.
"There's been a slow progression of therapies -- first there was Visudyne, which slowed the progression in some people, then Macugen, that slows the progression, then came Lucentis and Avastin, and for these drugs there's the possibility of improvement (of vision), which we've never seen before," Rosenfeld said.
According to Genentech, patients are not only able to read and drive again, about 40 percent can read three more lines on the eye chart than they could before the treatment. Avastin has had similar results for some patients.
"We just tried (Avastin) in a couple of patients at first with miraculous results," said Rosenfeld, who practices at UM's Bascom Palmer Eye Institute and has been involved in drug trials for wet AMD treatments for more than a decade, including Lucentis.
"We published those (Avastin) case reports," he said, and discussed his findings at a national meeting of retina specialists about a year ago.
"Outside the U.S., people can't really afford Lucentis," he said. "This spread like wildfire, so by the time the World Congress (of retina specialists) was held in February, the whole world was treating patients."
Rosenfeld said one Wall Street analyst estimated that Avastin had captured 80 percent of the market before Lucentis won FDA approval.
"It just goes to show you that if you provide an effective drug for an unmet need at an affordable price, there is no need for marketing and advertising," Rosenfeld said.
People who have Medicare, which covers the cost, usually choose Lucentis, he said. But people who don't have a supplemental policy may opt for the cheaper drug because the Medicare co-pay for Lucentis is about $400 and most people would have to pay that once a month.
Rosenfeld said the National Institutes of Health may sponsor a trial comparing Lucentis and Avastin.
While Kleinfeld's sight has been restored in the eye treated with Lucentis, there is still no treatment for the eye that lost vision years ago. There are no drugs that work for that. Some research is being done in animals using embryonic stem cells in the hope of being able to grow replacement tissue that will restore sight, but experts said clinical trials in humans are likely years away.
i am praying for some good news for you tomorrow.
Typical know-nothing vermin. Try adult stem cells.
No cheers, unfortunately.
The photo is fine, please change the tagline.
Cheers!
Thanks, so much.
U am also having my evalation for my second catarac surgery .
Maria
I am 37 years old, and 2 weeks ago, I was diagnosed with normal tension open angle glaucoma. In my left eye I have already lost some sight, in my right eye, it seems to be in the preglaucoma stage. To say the least, for the past two weeks, my thoughts have been constantly on the idea of being blind in the coming years. So any hope for anyone is a plus to me.
Hopefully in your left eye you had only minimally lost peripheral vision. That is the case with many of my early glaucoma patients; we are able to arrest progression of the disease before additional peripheral vision is lost. The all important central vision is of course, in glaucoma the very last thing to be affected. It sounds like you are a LONG way from that happening.
These days, with timely and proper care it is rare for patients to lose their sight entirely from glaucoma. NTG formerly was somewhat of a more unusual diagnosis than it is today. Technology had advanced and has allowed us to obtain a much greater understanding of early damage to susceptible anatomy of the eye.
Obviously, I do not know the particulars of your case, but if you follow your doctor's instructions, chances are you will suffer no additional vision loss.
The post below yours suggests that you seek the best specialist you can find. Quite frankly, in the vast majority of cases, that is wholly unnecessary, as nearly all glaucoma cases can be efficiently and successfully managed by an optometrist or general ophthalmologist. A responsible doctor will certainly refer you for more specialized care if your case is a complicated one.
Best wishes on your future ocular health.
"Medical technology is so good now, that if you will just do what the Dr. says and be really faithful with your meds, the prospect of having a long eyesight lifetime is great."
That is absolutely correct.
We can thank God for some significant technological advances that have provided us much greater insight into early damage from the elevated pressure (or sometimes, so-called normal pressure), of glaucoma. These same technologies also allow us to much better MONITOR for progression of the disease.
For all others Freepers reading this, please get screened. It takes only a few seconds, is not in anyway invasive, and is very inexpensive. It literally maps the thickness of your optic nerves and compares it to the rest of the population in your age, gender, and ethnic group. If it comes back normal, that's it, if not you then advance to other tests, and it could save your eyesight by catching it early.
While I have no doubt these drug therapies work for many people, I'm dismayed that so few doctors demand their patients with failing eyesight ALSO take vitamins A, C, E, amino-acid-chelated zinc, beta carotene and lutein. Some should also benefit from the herbs eyebright, bilberry, gotu kola, pycnogenol and possibly, grape seed extract.
D'oh! Almost forgot: American MDs have taken no more than 5 hours of nutrition classes in med school, if any at all, while they're subjected to dozens and dozens of presentations by pharma reps every year. I musta forgot to take my memory pills...
And the amino acids taurine and glutathione.
Gooseberry any good? I thought the chinese were doing something with it.
Apparently so! And I hadn't even known about it until your question prompted me to look it up. In fact, it seems to be a good all-around anti-oxidant and free radical scavenger. See: http://snipurl.com/uvid
I got some bad news from my Optometrist at my annual eye exam last week. He has spotted the early stages of Macular Degeneration in my right eye. Up until the visit I had no clue what the disease was.
So far taking using the eye exam for it, I have symptoms. Can anyone tell me how fast it progresses? I am 48, and dang I don’t want to lose vision this early, even if it is only one eye.
He did suggest adding dark leafy vegetables to my diet ,like spinach.
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