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Pre-Retinal Boat Hemorrhage Proliferative Diabetic Retinopathy | Randall Wong, MD Retina Specialist

Vitreous Hemorrhage in a Patient with Diabetes

This a vitreous hemorrhage.  The patient has a 30+ year history of Type 1 diabetes, has had cataract surgery in both eyes and never had laser or vitreo-retinal surgery for treatment of her diabetic retinopathy.

Essentially, she has been doing very well.  I see her at least twice a year to insure there is no diabetic macular edema and no sign of proliferative diabetic retinopathy.

She has been complaining of a “pixelated” change to the vision of the left eye.  (Honestly, as I told her, I have no idea what “pixelated” means.)

Dilated Eye Examination

Her examination started off normally.  The essential information is as follows;

61 Year Old Female
Bilateral Cataract Surgery
Last Recorded A1C: 8.0
AM Sugar:  90

Vision:  20/20 OD (Right Eye)
20/25 OS (Left Eye)

IOP:  17 OD
20 OS

Every patient gets their pupils dilated so I can examine the retina.  Examination of the retina is paramount in patients with diabetes.

Of significance is that her vision was excellent!

Vitreous Hemorrhage

After dilating her pupils, I was able to diagnose a vitreous hemorrhage.  This is the cause for her “pixelated” vision.  For teaching purposes:

  • This is a photograph of the left retina
  • The scalloped areas are “boat hemorrhages” formed by blood trapped between the retina and the posterior vitreous.  Blood is trapped in a “pocket” between the surface of the retina and the posterior vitreous
  • The top areas are horizontal and “level” due to the effect of gravity – hence,  the “boat”
  • In the larger hemorrhage, notice that the underlying normal retinal blood vessel is hidden – gives you an idea of the actual location of the bleeding

Diagnosis of Proliferative Diabetic Retinopathy

There are many causes of vitreous hemorrhage, but the more likely cause is related to diabetic retinopathy, especially in the absence of a tear in the retina.

While almost every patient with diabetes will develop some early degree of diabetic retinopathy, far fewer develop proliferative diabetic retinopathy.

Proliferative diabetic retinopathy (PDR) is defined as the stage of diabetic retinopathy where abnormal blood vessels, aka “neovascularization,” form somewhere on the retina or elsewhere in the eye.

Neovascular blood vessels are extremely fragile and can bleed easily causing a vitreous hemorrhage.

Sometimes the blood mixes throughout the retina and sometimes, as in this case, the blood remains localized and a nice picture can be obtained.

Vitreous Hemorrhage

In this particular case, my job is to insure that the blood is from the diabetic retinopathy.  As I said above, a retinal tear could also cause a vitreous hemorrhage, so in the absence of a retinal tear or other problem, I can safely observe (i.e. do nothing and simply wait) to see if the hemorrhage resolves on it’s own.  If there were a tear, I would need to treat the tear.

I’ll see this patient back in a few weeks.  The best treatment for this stage of the disease is laser treatment (aka panretinal photocoagulation).

Laser may be attempted in the office if enough of the hemorrhage clears on it’s own.  If not, vitrectomy can remove the blood and laser be performed at the same time.


Laser Treatment for Diabetic Macular Edema

Laser photocoagulation is still the best treatment for diabetic macular edema.  Diabetic macular edema, or DME, is the most common complication of diabetic retinopathy and it will affect almost everyone with the eye disease.

DME is also known as CSME (clinically significant macular edema).  The two terms are exactly the same for our purposes.

Before Laser Treatment

Diabetic macular edema before laser treatment.
Click to Enlarge

This is a retinal photograph of a patient with diabetic macular edema.  The white spots and flecks are evidence of chronic swelling of the retina from diabetes.  The swelling involves the macula, the most sensitive portion of the retina and causes loss of vision.

The goal of any treatment, laser, steroid injections or anti-VEGF injections is to reduce the swelling.  If the swelling improves, it is highly likely the vision improves, too.

Usually, a fluorescein angiogram is performed to demonstrate where the normal retinal blood vessels are leaking.  Using the energy of the laser, the areas of leakage are heated and this usually, but not always leads to improvement of the swelling.

Treatment can involve anywhere from a few to dozens of burns…all depending upon the number leaks.

Laser treatment to the center of the macula could lead to a permanent blind spot in the vision and, therefore, is not always the best treatment for every patient.  In these types of cases, intraocular injections of anti-VEGF or steroids might be a smarter option.

Laser Treatment Reduces Macular Edema

This is the same retina several months after laser treatment.  Note the white spots have all disappeared.

Diabetic macular edema after laser treatment.
Click to Enlarge

After 4-6 months, I can usually tell if the laser treatment is effective or needs to be augmented (ie. repeated).  At times, I’ll know I’ll need to treat with a combination of laser and intraocular injections of Avastin, steroids or even Ozurdex.

The laser treatment for diabetic macular edema is very similar to weeding a garden.  It is not a cure, and will have to be repeated.

What Does This Mean?

There are a variety of treatments for diabetic macular edema.   Laser treatment is still the standard of care for treating this common condition seen with diabetic retinopathy.

Though we have a variety of effective treatments available, we still don’t have a cure.  The best advice remains regular examination and treatment as early as indicated.

Randall V. Wong, M.D. 
Ophthalmologist, Retina Specialist
Fairfax, Virginia

Loss of Vision in an Old Friend

Finding the right doctor for diabetic retinopathy involves trust and friendship.I had an old friend visit me this week.  AB and I met when I was a young doctor in Baltimore.  He was referred to me for treatment of his diabetic retinopathy. Eventually, I operated to remove a vitreous hemorrhage resulting from his proliferative diabetic retinopathy.

For several years, we saw each other twice a year.  He retired about 8-10 years ago and moved to Florida.  There are lots of eye doctors there!

I don’t think we have seen each other for 8-10 years.  As you know, I now practice in Virginia.  He found me on the Internet.

70+ YO Male With Progressive Loss of Vision

When I get to the office, I glance over the patient schedule for the day.  I recognized AB’s name instantly and was excited to see him.

He hadn’t changed much.  I recognized him from across the waiting room, talking with some of the other patients.  He is now in his early 70’s and has had diabetes for 40-45 years.

He told me I’ve gained weight.  He looked as I remembered him, that is, I couldn’t return the  “compliment.”

He said he has had slow progressive loss of vision over the past 6 months.  Reading road signs and watching TV had become increasingly difficult.  He also griped about the last retina doc he saw in FL…didn’t like him at all.

Possible Causes

Diabetic retinopathy can not be cured, but we are often successful maintaining status quo…provided regular checkups occur.

AB not liking his docs could have a couple of meanings;  he doesn’t go back as often as he should, and/or perhaps he didn’t like the news he received from the docs.

The top possible causes?  Diabetic retinopathy (specifically diabetic macular edema), poor sugar control, needs new glasses or cataracts.  While there are many more causes of loss of vision, I thought these were the most likely.

After complete dilated exam, I was happy to report to him that he needed cataract surgery and, most importantly, there were no signs of diabetic macular edema nor active proliferative disease.

What Does This Mean?

Find a doctor who you trust.  That’s the definition of the “best doctor.”  It becomes crucial for patients suffering from long-term, or chronic, diseases such as diabetes or diabetic retinopathy.  All diabetic patients need regular eye exams for diabetic retinopathy.

If you don’t like your doctor, you aren’t likely to believe what she has to say and you won’t go as often as you should.  Simple human nature.

I expect AB to return to 20/20 vision after successful cataract surgery despite his age, length of being diabetic and the history of proliferative disease.

I noted his weight was stable, hinting AB is very disciplined and, unlike me, has been able to control his weight over the years.  I am not sure if there is any causal relationship between good vision and stable weight/diabetic control.

My point is that the disease is not certain to cause blindness or even severe loss of vision and I wanted to share a good story of seeing well despite chronic disease…and a trusting friendship.



Iluvien Marches Forward in Europe

Iluvien advances in the regulatory process for use in the treatment of diabetic macular edema in Europe.

Similar to the FDA process, Alimera announced the “positive outcome of the Decentralized Procedure (DCP)” for use in Europe.  The European process now involves a national phase of the DCP where a panel of countries will need to recommend Iluvien for medical use.

Alimera Sciences’s efforts for FDA approval of Iluvien in the United States were stymied in 2011 citing concerns over safety and requesting additional clinical trials.

Iluvien to Treat Diabetic Macular Edema

One of the more common symptoms of diabetic retinopathy is loss of vision due to swelling in the retina, more specifically, in the macula.  This is called Diabetic Macular Edema (DME).

The macula gives us central vision.   When fluid accumulates within the macula, the vision worsens.

The gold standard for treatment of DME has been laser treatment to the affected areas; however, only the areas next to, but not in, the macula can be treated.  If the macula were treated directly, then permanent blind spots might develop.

This means that not all patients can be treated.  Some patients have diabetic macular edema, but the source of leakage is in the central macula.  These patients can not receive laser treatment.

Alternative include intravitreal injections of steroid or anti-VEGF (such as Avastin or Lucentis).

Iluvien, similar to its cousin Ozurdex (already FDA approved, but for the use of retinal vascular occlusions), is an injectable sustained release device that will release steroid for up to 36 months!  Iluvien has hopes of being the first sustained release delivery system for the treatment of diabetic retinopathy.

What Does this Mean?

I am a big fan of Iluvien.  I like what Iluvien represents.

Iluvien represents an emerging treatment for diabetic macular edema, a disease that clearly needs to be treated in a variety of ways.  Ophthalmologists are limited in our ability to treat these patients as not all patients with this sight threatening complication are candidates for laser treatment.

Iluvien also represents hope for the future, not just for DME, but for sustained release drug delivery.  While the future of Iluvien in the U.S. is beyond my scope, I am glad to see that the technology is still viable…somewhere.

While we may not see Iluvien available here in the US, perhaps its approval and use in another country will be enough for a company such as Alimera Sciences to sustain them as a business and allow them to continue their research and development of newer technologies.


Still No Iluvien

FDA Denies Alimera Sciences' Iluvien for Treatment of Diabetic Macular Edema


Alimera Sciences fails to get FDA approval for Iluvien.  Iluvien is a sustained release drug delivery system that releases a steroid into the eye for the treatment of diabetic macular edema.  Alimera received the denial late last week in a letter from the FDA.

Implant Too Risky

In short, the FDA still has concerns about the safety of the new drug.  Original concerns about cataract formation and IOP (intraocular pressure) still remain despite additional safety data submission.  The FDA has stipulated additional clinical trials must be performed to answer the risk/benefit concerns.

Iluvien was anticipated to be the second sustained release drug for the treatment of a retinal disease.  The first drug, Ozurdex, was approved by the FDA for treatment of retinal vascular occlusions (e.g. CRVO, BRVO).  Ozurdex received FDA approval in 2009.

Docs Need Options for DME

Iluvien was to be indicated for the treatment of diabetic macular edema, a very common complication of patients with diabetic retinopathy.  Typically, patients receive laser treatment as a first line treatment, but alternative treatments have been long needed as laser can not be performed in everyone.

Intraocular injections of steroid or anti-VEGF medications such as Avastin or Lucentis, have also been used to treat diabetic macular edema over the past several years, but the use of these agents is “off label.”

The sustained release device is injected into the eye and will release a steroid, fluocinolone, for up to 36 months.  Shorter acting steroid injections have demonstrated favorable results and it was anticipated that a sustained release system might offer a realistic benefit of better drug levels and little need for reinjection.

What Does This Mean? Certainly, I am not in a position to remark about the FDA decision. There are many patients in whom laser is not an appropriate treatment.  There is no FDA approved alternative.  Ophthalmologists, including myself, have been using short acting steroids and anti-VEGF injections to treat these “no laser” patients.

Moreover, Iluvien would have validated sustained release drug delivery systems.  Ozurdex was first and Iluvien would have been the second delivery system designed for injection into the vitreous.

A second approved product, regardless of indication, would have been a significant endorsement for injectable sustained release systems.  Sustained release devices for macular degeneration (sustained release drug delivery of anti-VEGF), post-operative medications and glaucoma seem logical.



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Two Lasers for Diabetic Retinopathy

Laser Treatment for Diabetic Retinopathy

There are two different laser treatments to treat diabetic retinopathy.  One laser treatment is used to treat diabetic macular edema, the most common “complication” of diabetic retinopathy.  The second laser treatment is used to treat proliferative diabetic retinopathy (aka PDR), yet far fewer people develop this potentially blinding stage of the disease.

Same Laser Used for Both Treatments

Macular edema is treated with “focal” laser treatment.  The laser is used to treat/burn/cauterize those areas of blood vessels that are leaking near the macula.  The treatment is focused to treat certain specific areas, hence “focal” laser.

Proliferative diabetic retinopathy (PDR) is treated with “scatter” or “pan-retinal” photocoagulation (PRP).  The peripheral retina is “scattered” with laser burns.

Some Patients Need Both Laser Treatments

The timing of the treatment can be crucial.  Treating the PDR (proliferative diabetic retinopathy) before the macular swelling is controlled, or treated, can lead to progressive loss of vision because the PRP (used to treat PDR) can worse the macular edema.

I prefer treating and controlling the macular swelling first, before treating the neovascular disease (PDR).  Depending upon the situation, however, I don’t always have this luxury as sometimes the PDR is so advanced that we can not wait.

Remember, the neovascularization can cause blindness.

What Does This Mean? In most cases, patients need only one or the other treatment.  Macular edema is treated with focal laser and PDR is treated with PRP.  In the unlikely situation where patients need both…

When possible, I’ll treat the macular edema with focal and wait several weeks, or months, to treat with scatter laser.  I don’t want the macular edema to worsen.

Macular fluid causes decreased vision (patients can tell).  Worsening macular edema means lousy vision….and anxious patients.

Avastin, however, has improved my ability to treat those patients with both macular and proliferative disease.  Avastin (or Lucentis) allows me to treat both the PDR and macular edema…it buys me time!


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Alimera Sciences Says Iluvien Effective at 3 Years

Iluvien, a sustained release drug-delivery system for the treatment of diabetic macular edema, may be getting closer to possible FDA approval.  The parent company, Alimera Sciences has resubmitted additional safety and efficacy data as requested by the FDA last year.  The FDA requested that they be given data extending for a 3 year period instead of the 2 years in the new drug application.

Iluvien is Effective for Diabetic Macular Edema

Iluvien may be an effective new treatment for diabetic macular edema.  In theory, patients that require treatment for this common complication of diabetic retinopathy may receive an injection of Iluvien.  Iluvien will then release a steroid over several months and the company is trying to prove that it provides a benefit to the patients, in this case, the vision improves.

Such safety and efficacy data were presented recently to the public at a large ophthalmic meeting in FL last month.  The company has also submitted this data to the FDA (Food and Drug Administration).

About 30% or More of Patients Improve with Iluvien

In short, the company performed two large clinical trials, the so-called FAME study showed that about 33% of patients  receiving the implant noted an improvement in vision.  Of significance is that this improvement, according to the company, was present after 3 years.

Last year, the FDA also asked for a review of the manufacturing process of Iluvien, but I am not aware of any specific elements that were made public.  These, too, have been addressed.

What Does This Mean?

About a year ago, Alimera Sciences submitted the new drug application (NDA) for it’s proprietary intraocular drug delivery system for the treatment of diabetic macular edema (DME).

The NDA is the last step to acheiving FDA approval for a new drug.

Last December, the FDA failed to approve the NDA, but, instead requested more data about the efficacy (how well a drug works) of Iluvien.  This was provided this Spring.

So…we continue to wait.  There should be some decision made this Fall, but my guess will be that it is favorable.

If you remember, Ozurdex, the first sustained release intraocular drug delivery system was approved for treatment of retinal edema caused by retinal vascular diseases.

It may be that a second such device may be shortly approved for the treatment of diabetic retinopathy.  While this further endorsed the sustained release technology, it will be a breakthrough that allows significantly more people to be helped that presently have few options.


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Laser and anti-VEGF Best Treats Diabetic Macular Edema

Laser and anti-VEGF Best Treatment for Diabetic Macular Edema

Treating diabetic retinopathy with both laser and anti-VEGF injections may be the best way to treat patients with diabetic macular edema.  Diabetic macular edema is the most common “side effect” of diabetic retinopathy and is the leading cause of vision loss in patients with diabetes.

The results of a large, multicenter, randomized clinical trial compared several permutations of laser and the anti-VEGF drug, Lucentis.  Intraocular steroids were included as well.

To date, standard treatment, or the standard of care, includes treating the retina with laser photocoagulation to retard the loss of vision.  Not all patients can be treated with this modality and intravitreal injections of anti-VEGF and also of steroids have been found to be useful treatment for those in whom laser is not applicable (myself included).

Whether or not a patient receives laser or injections, the treatment of diabetic macular edema is akin to “weeding” a garden.  The treatments are not a cure, and just like weeding a garden, the “leakage” may be controlled for a time, but only to return.

In short, diabetic macular edema recurs and requires retreatment.

The study found that injections of Lucentis/ranibizumab followed by either prompt or deferred laser for 6 months, was superior to laser treatment alone.   The study also found that this combination was superior to a similar combination treatment with intraocular steroids.

In addition, intravitreal injections of anti-VEGF and laser (immediate +/- deferred) led to the most improvement in vision, resolution of macular edema and, over a two year period, required fewer treatments!

What Does This Mean?

Diabetic macular edema is often difficult to treat.  The number of tools we have to treat the disease was quite limited until the introduction of intraocular steroids and anti-VEGF.  Over the past few years, because of these additional modalities, we have been able to help more patients than with just laser alone.

This new study not only validates the use of anti-VEGF medications, but also hints that anti-VEGF may be superior to steroids.  More studies will tell.

Most importantly, however, the study describes a treatment regimen that leads to improvement, stabilization and reduction in the number of treatments!

This means better vision and fewer office visits, right?

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VEGF-Trap Gets Closer to FDA Approval

VEGF Trap for Macular Degeneration and Diabetic Macular Edema

VEGF-Trap (aka aflibercept), another anti-VEGF drug, moves closer to FDA approval as it received “priority review” status.  This status means that the FDA process will be accelerated and the drug can be reviewed in 6 months versus the usual 10 month period.  Alfibercept is another injectable drug that may have an effect on choroidal neovascularization in wet macular degeneration.

In the press release, Regeneron Pharmaceuticals, Inc., cited an incidence of almost 200,000 new cases of wet ARMD in the U.S. alone.  It is the leading cause of new blindness in patients 65 and older.

As with it’s predecessors, Macugen and Lucentis, the company must prove to the FDA that the drug is effective and safe.

Regeneron has also started Phase III clinical trials for VEGF-Trap for the treatment of diabetic macular edema.  There will be two studies, an international study and a North American study.  These trials, too, will be conducted to test the safety and efficacy of alibercept for retinal swelling caused by diabetic retinopathy, or diabetic macular edema.

Diabetic macular edema is the leading cause of decreased vision in patients with diabetes under the age of 50.  Similar studies are underway for Lucentis and Avastin.

What Does This Mean?

On one hand, this is not new news.  Macugen, Lucentis and Avastin have been used for several years for the treatment of wet macular degeneration.  VEGF-trap is the same type of drug as the aforementioned.  VEGF-trap is likely, in my opinion, to gain FDA approval if;  it improves vision better than Lucentis and/or it requires fewer repeat injections to stableize the eye.

On the other hand, using VEGF-Trap for the treatment of diabetic retinopathy will be the first drug to gain FDA approval.  Until now, we (retinal specialists) have been using Avastin and Lucentis “off label” for the treatment of DME.  Approval of VEGF-Trap will validate our suspicions that this is a worthwhile treatment for diabetic retinopathy.


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Diabetic Macular Edema: Have No Fear

Diabetic Macular Edema,




Diabetic macular edema (DME) is swelling in the retina caused by diabetic retinopathy.  More specifically, the swelling is located in the macula, the functional center of the retina.

Diabetic Macular Edema Occurs In Almost Everyone

DME is the most common “side effect” or complication of diabetic retinopathy.  It should not be feared, but rather, it should be expected.  Almost every diabetic patient will develop some degree of macular swelling in their lifetime.

Diabetes can be considered a disease of blood vessels, caused in some way by high sugar levels.  For reasons that are not completely known, the blood vessels in the retina start to leak, both blood and the fluid component of blood.

As the leakage nears the macula, we get concerned as swelling in the macula leads to loss of vision.  The idea of treatment is to prevent the fluid from ever reaching the macula.  If fluid has already developed, treatment may prevent further leakage (and thus preserve vision) or possibly decrease the swelling (and maybe improve vision).

Laser Treatment is Only Approved Treatment

The only FDA approved treatment for diabetic macular edema, aka clinically significant macular edema (CSME), is laser treatment.  The laser is used to burn those areas around the macula that are leaking.  Often, the laser results in stablizing the retina and preventing further leakage.

Laser is Painless

The laser does not hurt.  There are no nerve endings underneath this portion of the retina.  The treatment may last just a few minutes and is accomplished while you are sitting at the laser.  In fact, the visit should mimic a routine dilated exam.

After treatment, no “healing” is really needed.  I personally do not recommend any drops, patches or time off from work.  Your doctor’s recommendations may vary.

Laser treatment for diabetic macular edema takes several months to start working.  After 4-6 months, I can usually tell if more treatment will be needed.

What Does This Mean?

Laser treatment for diabetic macular edema is the gold standard.  While DME is quite common, the treatment works best if instituted early in the disease process, preferably while the vision is 20/20.

Not all patients can be treated with laser.  Other treatments for DME include  intraocular injections of Avastin or Kenalog.  Using any of these tools, almost everyone with diabetic retinopathy may be treated.

Regardless, fear not, the treatment for the disease is quite successful in preventing further vision loss.  It is painless, safe and effective.

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Currently, I see patients with retinal diseases; macular degeneration, retinal detachment, macular holes, macular pucker within several different'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
Ph: 703.534. 4393
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Dressler Ophthalmology Associates, PLC
Randall V. Wong, M.D.
Contact: Ashley (Surgery/Web)
Chrissy Megargee (Web)

A: 3930 Pender Drive, Suite 10 • Fairfax, Virginia 22030
Ph: 703.273.2398
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