Happy New Year! Thank you for your support this year.
We started in April ’09 and now have over 900 “visits” per 30 days.
I write for other blogs to bring attention to ours. I tell my patients and doctors. It is working very well. The concept of creating a credible source of health information is slowly catching.
My goals for this year are to continue to increase the readership. I will continue to write, but will also be trying to form relationships with other sites of related material, for instance, credible sites offering information on diabetes.
I will continue to preach about social media and its benefits for patients and medical practices. I have started writing regularly for “Physician’s Practice” Notes; a blog for physicians.
I want to wish you all a Happy New Year and all the best for 2010. Thank you so much for making our first year such a success.
This site is for patients with macular degeneration and diabetic retinopathy. I should really use proper grammar to say that this web site is for patients with either macular degeneration or diabetic retinopathy. A subtle difference.
Patients usually have one of these diseases or the other, but not both. I do not believe that this is well documented. Most patients have either diabetic retinopathy OR macular degeneration. I have, but rarely, seen patients that develop both. I don’t know why.
That’s it for 2oo9. Here are a few articles that were popular over the year.
The risks and complications of injections into the eye are low. The most dreaded complication of intravitreal injections is infection inside the eye (aka endophthalmitis). The risk of endophthalmitis is reported to be about 0.09%. Endophthalmitis can cause blindness.
As more and more intravitreal injections are delivered for the treatment of diabetic retinopathy and wet macular degeneration, the concern for causing blinding infection becomes greater. The rates of infection have always been low, in fact, so low, it is difficult to estimate and study.
Complications of intraocular injections include;
Subconjunctival hemorrhage – bleeding outside the eye (scary looking), but benign
Retinal Detachment and Infection are the biggest concern. The other “complications” are rather soft and either don’t cause damage or are reversible (cataract and vitreous hemorrhage).
Retinal detachment can occur if the needle enters the eye in the wrong spot and causes a hole/tear in the retina. Additional surgery may be needed depending upon when this complication is diagnosed. Retinal detachments can potentially cause permanent loss of vision depending upon timing.
Endophthalmitis is a nightmare. It may occur in any intraocular procedure where the eye is penetrated by a surgical instrument. It happens so infrequently, that it is difficult to really measure the rate at which it occurs and to study just how it occurs. In theory, bacteria on the outside of the eye gets inside. Does this happen during surgery, or, after? We don’t really know.
You Have a Dirty Mouth – The eye, nose and mouth are all connected. This is why you blow your nose after crying. Your eye is as dirty as your mouth and nose. There is a lot of bacteria that can cause an infection.
Pre-Operative Antibiotics are controversial. In theory, it makes sense to treat the eye with antibiotics prior to anticipated surgery or injection. Many cataract surgeons prescribe antibiotic drops prior to surgery, but many don’t. The rate of infection is so low, it is hard to measure. Many retina specialists prescribe antibiotic drops prior to intraocular injection, but many don’t (I do).
A study was just published that found no difference in the rate of infection between using antibiotics before (and after) injection compared to no antibiotics. Over 3800 injections were studied. What is crucial; however, is the use of a lid speculum (small wire device that keeps the eyelids spread apart) and the application of a topical iodine/povidone antiseptic.
What Does This Mean? My point is to highlight that the risk of blindness due to infection is low in intraocular injections. As injections become more widely used for diabetic retinopathy and macular degeneration, we’ll be able to better define the rate and causes of this potentially blinding complication. Incidentally, as the use of sustained release technology is emerging, infection will become less of a concern as fewer ‘injections” will be necessary.
™Alimera Sciences’ “Iluvien®” moves closer to FDA approval for the treatment of diabetic macular edema. Iluvien is an extended release drug delivery system designed for direct intravitreal injection to the eye. Iluvien will release a steroid, fluocinolone acetonide, for up to 36 months to treat retinal swelling. The company has announced pivotal results in the ongoing FAME (Fluocinolone acetonide in diabetic macular edema) study. This is a phase 3 FDA clinical trial.
An earlier post covered Iluvien’s safety and efficacy in phase 2 trials for the treatment of diabetic macular edema.
Diabetic Macular Edema is the most common complication of diabetic retinopathy. The traditional laser for diabetic retinopathy has been usual treatment for about 30 years. I have written previously about the emergence of new treatments and new technologies to treat the diabetic macular edema. Intravitreal steroid injections, anti-VEGF and sustained release intraocular drug delivery systems are all the rage.
FDA Clinical Trials dictate how medicines are approved for treatment of disease in the U.S. I have always cautioned that you must consider a “treatment” only if it has already been FDA approved. Most of what is advertised as treatment is neither FDA approved nor even studied.
There are 4 different steps to passing the FDA requirements. There are 3 phases of clinical trials (sometimes an additional phase 4 is required) and the NDA (New Drug Application).
The phase 3 clinical trial (FAME) is almost complete. The study will proceed to 36 months. The early phase 3 findings indicate improvement in vision in about 25-30% of patients after the first 24 months of the study.
What Does This Mean? This is huge. It means that there is merit to what the company anticipates. Technically, phase III trials determine if the drug is useful and confirms safety.
New Drug Application (NDA) is usually the last step for a company, or sponsor, to be allowed to market and sell the drug. Alimera expects NDA submission later in 2010 after completion and analysis of the phase 3 data.
Alimera’s Iluvien is close to reality for the treatment of diabetic macular edema.
A company, Ophthotech, recently announced their drug is now funded to enter Phase II FDA trials for testing.
Their new drug, E10030, is an aptamer (similar to an antibody) targeted against “Platelet Derived Growth Factor.” The aptamer is designed to specifically bind to PDGF and prevent “plugging-in” to its receptor.
The company feels that the combination of the two drugs gives a better improvement than Lucentis/anti-VEGF alone.
What Does This Mean? Phase II FDA trials are meant to test for safety, but more importantly, are also designed to test for efficacy of a drug. In other words, Phase II trials determine how well a drug works. Many drugs fail at this point.
The identification of another factor leading to wet macular degeneration is intriguing; however, as are the claims that the two agents work better than anti-VEGF alone.
Also, I bring this drug to your attention to highlight that it is a potential new drug and not even close to approval, yet you may hear that this is a new “treatment.” It is not and has a long way to go. Many people will be touting this as a new therapy.
The FDA has a total of 4 clinical trials. We are several years away from significant results.
“I Read it on the Internet” Most of what I read on the internet, regarding health information, is bunk. Whether it is advice on diets, exercises, medical treatments, etc., most is off target, non-factual and opinionated and biased. People are likely to believe what we read on the internet as gospel because……….well, it is on the internet! As if the internet is the ultimate stamp of “authority.”
Lack of Credibility Most web sites, especially health, have no credibility whatsoever. There is no review system in place to filter information. In time, this will come, but for now, read carefully. Read and look for sites that are written by authorities. In my case, the content of my web site should be more credible than others. I am a physician. I am a retina specialist. This makes me an authority on retinal diseases such as diabetic retinopathy, macular degeneration and retinal detachments.
True vs. Perceived Authority True authorities are hard to come by, especially on the internet. The world’s most famous authority on “snipes,” isn’t necessarily the authority on the internet. The “perceived” authority will be found on the internet. The “perceived” authority is the person who takes the time to publish about “snipes,” and this may even include work by the true authority.
In other words, the person that publishes the most about a topic is more likely to be the perceived authority and is easily found with you “Google” a topic, whereas the true authority may lie dormant and be lost on the internet.
It’s Easy to Get On The Internet It is so easy, I’ve done it. It is easy to create a web page or blog. Simple software is available for free. Sophisticated software is nominal. I use a company to “host” my web sites. Overall, it costs less than 10 dollars a month. My point is that it is easy and cheap. You basically just need a computer.
What Does This Mean? It does not mean that everything you read is bad information. Most of the health information on sites like WebMD and NIH is awesome and factual. These authorities have authored the content on the web pages. Be cautious about the source if you are not familiar with them. They are, however, often very hard to read. I find the information is too broad and not necessarily targeted to their readers.
Beware of Selling Beware of web sites that seem to promote health information and are trying to sell you something. For example, health supplements such as vitamins. I believe there is a conflict of interest. On my sites, I may eventually be selling something, but I promise it won’t compromise the credibility of what you read on my site. For instance, I won’t be selling “eye vitamins.”
Look for the “contact” information. If it is hard to find the author, or owner, of the web site, then I’d be suspect of the information.
Look for Credible Authorities. For instance, I’d recommend looking for medical sites written by ………….. doctors. As you move away from the doctors, the authority figures have less clout, but it is a good place to start.
The Internet is NOT a Doctor. You should still see a doctor. Use the internet to gain information and learn. Use the internet to ask your doctor better questions. The internet is an awesome place for information. You just have to figure out what to believe!
Tell Your Doctor! – Part of my charge is to create credible sources of information on the internet. By using our innate authority as physicians, I am pleading that more and more docs create sites like www.RetinaEyeDoctor.com. There are huge implications for my disseminating factual health information regarding diabetic retinopathy and macular degeneration.
Social Media If you find a site you like, comment, tell others, tell your friends and even your own doctors! You may even consider using social media to share your good news!
Most retina specialists are also surgeons. We operate on retinal detachments, advanced diabetic retinopathy………….and trauma. Trauma includes careless accidents involving projectiles………..like toys. This holiday season, think about eye safety.
Paintball– I hate this one. A compact canister fired at a high rate of speed. The fancier the gun, the faster the projectile. These things even can even travel around corners! The size of the paintball is a perfect fit between your brow and cheekbone. Thus, ALL the force is absorbed to the eye. I think the safety/protection is satisfactory, but the accidents happen “off the field” when the players are not expecting a shot to be fired.
I had a 14 year boy several years ago who developed a retinal detachment, had surgery and still went blind. The impact of the pellet was so severe, it detached his retina and severed his optic nerve. The other problem with paintball is that the age group is old enough to know right from wrong and may lie to conceal the truth to avoid punishment. Had I originally known a paintball was involved, we might have approached him differently.
Pocket Knife – I know many people that carry them for small odd jobs around the house; cutting string, small screw drivers, etc.
Then there was this “kid,” who tried to see how many times he could throw his knife and get it stuck into a tree. The knife bounced off the tree and landed in his right eye. The tip of the knife went right through the center of the cornea. While his retina never detached, the knife cut his natural lens and ruined his cornea. He needed a corneal transplant, removal of the damaged lens and a possible implant. He’ll need life long follow up. The “kid” was 19.
BB Gun – Believe it or not parents, BB guns are either fired on purpose at a “friend” or go off accidentally. I have had several cases (the term we substitute for “patients”) where the BB went directly into the eye. Most times it doesn’t penetrate the eye, but can still cause permanent damage.
Blood can fill the front of the eye and is called a hyphema. My 12 year old boy developed a cataract and is at lifelong risk for developing glaucoma; all due to the trauma.
The kids don’t think that these low-speed projectiles are dangerous and don’t bother to don safety glasses. They usually don’t even penetrate the skin, so the feeling is these are “safe.”
I have no opinion about “Air Soft.”
“Nerf Gun” That spongy material that has been around for generations can be blinding. My worst “toy story” is the kid who shot a Nerf dart at a friend. The Nerf dart had a suction cup at one end which was designed to stick to flat surfaces (e.g. window, refrigerator door, etc.). This guy modified the suction cup with a straight pin. I don’t think he meant it to get stuck right in his buddies eye. They were 9 years old.
The right eye of our little patient has now undergone at least 5 retinal surgeries. The cornea may need replacing soon due to the original accident and repeated surgeries. The visual potential? Legally blind, at best.
What Does This Mean? I am not advocating changing your shopping list. I am not advocating anything. All of these “toy stories” are true and have horrible endings. All of these patients were young and old enough to know better. They are unfortunate.
We have five kids. Our only rule – no real guns. They are the same ages of everyone one of my stories.
We have everyone one of the “toys” listed above except the high-velocity paintball guns. We encourage them about safety (especially eyes). We encourage them to have fun with their toys and to use them as they were meant to be used. We try not to over control. Accidents will happen.
And they come back for more! My patients love it because anti-VEGF injections usually work really well, especially if the wet form of macular degeneration is caught early.
Suspicion Confirmed When I examine a patient and suspect that a patient has wet macular degeneration, I’ll usually confirm the diagnosis by performing a fluorescein angiogram. Once confirmed, I’ll usually recommend intraocular treatment with Avastin. I have not used Macugen in about 3 years and only occasionally use Lucentis.
First Injection I usually discuss the whole procedure of delivering an intraocular injection and reassure everyone that it is a painless event. Prior to the actual injection, as I described in a previous post, antibiotic drops are to be used and a second prescription is given for the Avastin. The Avastin is prepared for us by an adjacent compounding pharmacy (a specialty pharmacy that breaks up the Avastin into smaller doses for ophthalmic use).
Series of Injections My usual practice is to commit to 3 treatments given every 6 weeks. After this short series, we reassess and determine if more injections are necessary. Some docs may give injections as frequently as every 4 weeks “come he** or high water.”
More……….please? Aissa and Dick, my teammates, can tell as soon as a patient walks through the door if the injections are working. They are ecstatic. They smile, they bounce, they can’t wait for the next injection! In general, the better the vision, the more aggressive I am at recommending additional injections. If we aren’t getting the visual results we had hoped, then maybe I’ll be less emphatic. So, after the first 3 shots, I’ll recommend more if there continues to be improvement. The additional shots decrease the chance of recurrence…..we think.
No More Needles! This can be good news or bad. I’ll recommend stopping the injections if I don’t expect any more improvement, or, we never improved at all. In this latter case, we are giving up and throwing in the towel. Sometimes the disease wins!
Shot Holiday After we stop injections, I warn that we are looking for signs of recurrence. Initially, I’ll usually see patients every 6 weeks and then less frequently if there are signs of stability. Any time I suspect that there is recurrence, or if there is a decreased vision or distortion, I’ll obtain a fluorescein angiogram to confirm recurrence. The fluorescein angiogram is the best test for this.
An OCT (Optical Coherence Tomography) is another test that is commonly used by retina specialists. In this scenario, it is usually used to detect swelling, or leakage, presumably from the neovascularization. It can not, however, actually confirm active neovascularization. It is used to monitor progress of the treatment.
What Does This Mean? This is how I “roll.” There are lots of variations to this regimen, but most retina specialists practice pretty similarly. Basically, we treat to seek improvement, then monitor for signs of improvement. This is truly one of the most rewarding things I do! Before injections (including PDT – see section on macular degeneration), we offered little hope of improvement from this blinding disease. The ability to change the natural course of this disease is miraculous!
Avastin, in many areas is the preferred treatment for wet macular degeneration. Avastin’s generic name is bevacizumab. It is the predecessor to Lucentis and both are made by the same company (Genentech/Roche). Avastin is the third intraocular injection and is also anti-VEGF.
is NOT FDA approved for the treatment of macular degeneration
is the standard of care for the treatment of macular degneration
is an antibody fragment against VEGF
blocks all isoforms of VEGF in the eye (there are six)
is FDA approved for the treatment of cancer
Confused? Yes, it is not FDA approved, but is the standard of care for the treatment of macular degneration. There is a difference between FDA approval and standard of care. In short, standard of care is what a prudent doctor would do in the same situation. FDA approval is necessary for a drug to be used in the U.S.
Avastin Fights Cancer and was introduced in 2004 for treatment of colon cancer and lung cancer. It is now approved for the treatment of breast cancer. As the story goes, some patients receiving chemotherapy for their colon cancer noted improvement in their vision. They must have had wet macular degeneration at the same time!
Genentech researchers were aware that anti-VEGF treatments may also be effective for macular degeneration and developed Lucentis. They were successful in gaining FDA approval for Lucentis and the treatment of wet ARMD (macular degeneration).
The Lucentis pricing structure bothered most physicians. Basically, it is very expensive for both docs and patients. Many doctors lost money using Lucentis and the patient responsibility is costly. Lucentis is priced at about $1950 per dose. Avastin is anywhere from $25 – $50 per dose.
The alternative became Avastin.
Avastin is also used “off-label” for the treatment of diabetic macular edema and proliferative diabetic retinopathy. This is not unique to Avastin, but is true for the other anti-VEGF medications; Lucentis and Macugen.
What Does This Mean? Avastin is a great alternative. Its use is well accepted in our community. I believe Avastin is at least as effective as Lucentis. Several studies support this. What is more interesting is that diabetic macular edema, wet macular degeneration and cancer all require VEGF! The common denominator?……………….blood vessels.
Lucentis™ is the second intraocular, anti-VEGF injection FDA approved for the treatment of wet macular degeneration. It was approved in 2006. It fast became the mainstay of the treatment for wet macular degeneration. It is still popular today among retina specialists for treatment of wet macular degeneration.
Facts About Lucentis
FDA approved for the treatment of Wet Macular Degeneration
Lucentis is a portion of an antibody directed against VEGF
Lucentis binds directly to VEGF
Lucentis is given as a series of intraocular injections
May be suitable for proliferative diabetic retinopathy
As with all the anti-VEGF intraocular injections, Lucentis is given as a series of injections. The frequency varies, but it is safe to say that most retina specialists recommend injections every 4-6 weeks. Originally, Lucentis was recommended for a complete year or more.
For our purposes, Lucentis is a portion of an antibody (specifically the Fab Fragment) directed against several forms of VEGF. It does not block all isoforms (types) of VEGF. Practically speaking, the antibody latches on, just as Macugen (an aptamer, but functions the same way as an antibody), to the VEGF molecule. The binding to VEGF prevents VEGF from “plugging-in” to the receptor. The receptor never gets activated. VEGF effects are blocked.
Lucentis is manufactured by Genentech (Roche). Genentech (Roche) also manufacturers Avastin™ (more tomorrow). Compared to most drugs in ophthalmology, Lucentis is pretty pricey. Though Medicare and other insurance companies do cover the cost of the drug, they do not cover the full price of the drug. The difference is usually paid out of pocket by the patient if there is no “gap” insurance.
What Does This Mean? Lucentis rapidly became popular for the treatment of wet macular degeneration. There were several reasons; effective marketing, “second generation” phenomenon (ergo, must be better) and the acceptance of intraocular injections overall. By 2006, more and more doctors were now comfortable with the whole “package” or idea of giving intraocular injections and so, too, were patients. The results were truly remarkable. The injections, whether Macugen (approved 2004) or Lucentis………….patients were getting better!
As with all the anti-VEGF drugs, there may be true implications for their use in the treatment of diabetic retinopathy. Remember that VEGF is implicated in vascular leakage, inflammation and neovascularization. Vascular leakage and neovascularization can occur in diabetic retinopathy. Inflammation is thought to be a key component as well. In theory, anti-VEGF should be a “slam dunk” for the treatment of diabetic retinopathy. Many small studies have already indicated that anti-VEGF is an effective treatment for diabetic retinopathy.
Currently, I see patients with retinal diseases; macular degeneration, retinal detachment, macular holes, macular pucker within several different practices.....it's a different arrangement, but it allows more continuous care with many eye specialists.
In addition, I am very accessible via the web. To schedule your own appointment, call any of the numbers below.
Virginia Lasik | Office of Anh Nguyen, M.D. Randall V. Wong, M.D. Contact: Layla
A: 431 Park Avenue, Suite 103 • Falls Church, Virginia 22046