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.
Ping
lol...cures poor eyesight and erectile dysfunction at the same time.
"My dad has macular such that he can see clearly enough in his peripheral vision to watch a Braves game on TV, but, of course, sees nothing in the center. Is this something that might be of help to a person in that stage."
The visual effects of ARMD are the same-loss of central vision, whether the mechanism is exudative maculopathy (wet ARMD) or the MUCH more common, non-exudative (dry) form.
A point to be emphasized: this irresponsible article failes to point out that the great majority of ARMD patients have the non-exudative form, which is not treatable, at least with this drug.
Even if your father has the exudative type of maculopathy, if the damage occurred some time ago, I would doubt that this drug would be of help to him; my understanding is that it has its greatest utility in patients CURRENTLY undergoing vision loss from the disease.
For your Dad, magnification is the best current solution. Applicable to the specific visual task you mention, TV viewing at intermediate distances, a spectacle-mounted telescope would probably be the best solution.
Of course he should check with his optometrist or ophthalmologist regarding the particulars of his particular case, and the resultant applicability of this, or any other specific treatment.
However, as to the following statement...
A point to be emphasized: this irresponsible article failes to point out that the great majority of ARMD patients have the non-exudative form, which is not treatable, at least with this drug....the title mentions the fact that this treatment is only for "wet" AMD.
"You know this how?
I've followed the studies and have been in conversation with a couple of retinal specialists."
"We're you involved in the trials?"
No. You?
"Is the data posted somewhere?"
Undoubtedly. Google the keywords. You will find that "success" and "success group" are at least very descriminately, if not narrowly, defined
But come on. One does not need to be a eye doctor, or a medical professional of any type, to have big red flags go up over a 95% success rate with any drug thrown at a BROADLY-DEFINED medical condition.
"...the title mentions the fact that this treatment is only for "wet" AMD."
Indeed it does, but then it goes on to make this grossly inaccurate statement:
"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."
ALL forms of ARMD are indeed the leading cause of blindness in patients over 55, BUT that includes the MUCH more common non-exudative form. Additionally, from the retinal specialists I have talked to the STAGE of the exudative ARMD is of significant importance in the treatment success.
My uncle has this and as a big reader, his quality of life has been seriously degraded.
I imagine this article was written by someone who lacks the professional experience necessary to delineate the finer points of this condition and was just trying (as was I) to give a general heads-up to folks with family members who have AMD.
"I imagine this article was written by someone who lacks the professional experience necessary to delineate the finer points of this condition and was just trying (as was I) to give a general heads-up to folks with family members who have AMD."
But the problem for those of us in the trenches, is that we have to be the bearer of bad news when such an irresponsibly optimistic article is published. That, inevitably positions us as the bad guys (shoot the messenger syndrome). It has already happened to a small extent here on this humble FR thread.
Much could be said here about the inherent sloppiness of "journalism" in general, but that is well covered elsewhere on Free Republic.
My sensitivity to this kind of information dissemination comes from the office full of patients I'll have to face tomorrow, who will be disappointed when we relay the REAL facts about this treatment.
But let me go back to my FIRST statement, for SOME it is a very promising therapy.
Yep - I almost passed out from lack of blood to the brain.
"You made the claim the results were less than honest - now back it up with the data, not anecdotal information."
I absolutely did NOT. I said the results were painted IN THIS ARTICLE with much too broad a brush. I don't respond to orders, look it up yourself. You will indeed see that treatment "success" and "success group" are much more rigidly defined than the article implies.
"Jonas Salk would be interested to know that."
A ridiculous statement, comparing PCN's broad, uneven effectiveness against SOME forms of bacteria, versus this irresponsibly open-ended statement regarding what is in actuality a specific neuro-destructive condition at a specific stage in the disease process:
"About 95 percent of patients regain their sight after treatment".
Interesting stuff ping.
You are in over you head, way over your head, so you respond with the blanket bull$hit call.
You don't even have a clue as to how much you don't know.
Go disturb $hit elsewhere. I have better things to do.
"My Mom started treatments earlier this spring. First shot did not seem to do much. Since the second shot (in the eye) her vision has been getting better. I note that she is not needing the special fluorescent light to read now. So far, so good."
Glad to hear that. Very glad. Until it is lost, we do not realize how crucially important optimum central visual acuity is in EVERYTHING we do.
When was your mother first diagnosed with exudative ARMD?
More apropos, when did SHE first notice that her vision was functionally decreased?
When treatment was first initiated, did it seem to her that her vision was still in the process of declining?
Thanks in advance for your reply.
"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."
This statement is incorrect if you go to www.fda.gov and read the original announcement. It should read that 95 percent MAINTAIN their current level of vision and about one third IMPROVE their current level of vision. Even so, this is a significant achievement and if the disease is caught early enough and treatment started, functional vision can be maintained.
She first noticed after laser surgury for skin cancer on her nose (abt 3yr ago? coincidence, who knows.) Diagnosis was a couple years ago as I recall.
If you know who is who, she is going to a retina specialist that covers the Pacific Northwest. I understand there is one other Dr. like him in LA. Fortunately he is 45min away. I've heard one patient came in from Montana as I was waiting during one appointment.
Also, as I recall, the retina Dr. did try a laser, to no avail.
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.