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Diabetic retinopathy Treatments

Iluvien Treats Diabetic Macular Edema for 3 Years

US ILUVIEN LOGOIluvien is now available in the United States!  Finally receiving FDA approval in late 2014, the injectable sustained release intravitreal implant  is on the market.

Alimera Sciences states that Iluvien (sustained release of fluocinolone) will release its drug for up to 3 years.

Iluvien Treats Diabetic Macular Edema

Diabetic macular edema is the most common vision threatening complication of diabetic retinopathy.  In essence, normal blood vessels of the retina become leaky due to the diabetic retinopathy.

Fluid accumulation in or near the center of the macula is called diabetic macular edema (DME).  This is also known as clinically significant macular edema (CSME) if you are a doctor.

DME often causes blurry vision and in extreme cases can cause legal blindness.

Therapy is aimed at stopping the leakage.  With time, the macular edema may “dry up.”

Treatment options include laser, anti-VEGF (e.g. Avastin, Lucentis, Eylea), intravitreal steroids (Kenalog) or sustained release intravitreal implants (Ozurdex, Iluvien).Size comparison of Iluvien to Pencil Tip | Randall Wong, M.D., Retina Specialist, Fairfax, Virginia

Iluvien is Injected Painlessly

Iluvien is injected directly into the vitreous.  The sustained release system will release fluocinolone for 3 years.  The actual “pellet” is small enough to fit inside a 25 gauge needle.  It is smaller and thinner than a grain of rice.  You may click on the image to enlarge.

By injecting directly into the eye, as with all intravitreal injections, only small amounts of drug are needed to treat the retina.

The steroid will chemically stop the retinal vessels, affected by the diabetic retinopathy, from leaking.

36 month Delivery

While intravitreal drug delivery is not novel, the duration of the product is unique.

Constant treatment for 36 months may have huge practical advantages; namely fewer offices visits and less testing.

The economics of this are intriguing.  The practical consequences are even more staggering.  In short, this could mean far fewer trips to the retina specialist for the patient AND the family.  Fewer office visits translates into fewer examinations and testing.

We’ll see.

 

 

 

 

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Diabetic retinopathy Treatments

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

Categories
Diabetic retinopathy Treatments

Iluvien Gains Ground

Iluvien Approved in EuropeIluvien continues to make progress outside the US for treatment of macular edema due to diabetic retinopathy.

Iluvien, a sustained release drug delivery system from Alimera Sciences, is a proprietary intraocular injection for the treatment of diabetic macular edema.  Iluvien releases a steroid for up to 36 months and may be a significant treatment for the most common “complication” of diabetic retinopathy.

Normal retinal vessels tend to leak the clear fluid part of blood into the retinal tissue.  If the fluid accumulates in the macula, vision is often decreased.  Treatment is aimed at preventing further accumulation of fluid and thus preventing further loss of vision.  Often the “swelling” can be fixed and vision improves.

Presently, diabetic macular edema is treated with laser, anti-VEGF medicines or steroids.  Unfortunately, treatment for diabetic macular edema is similar to “weeding a garden”…the leakage tends to come back.

Austrian Approval

Iluvien was just approved for use in Austria several weeks ago.  This marks the first sustained release pharmaceutical in that country for the treatment of DME (diabetic macular edema).

United Kingdom Follows Suit

More recently, the United Kingdom allowed marketing authorization for Iluvien, too.  This is the second EU (European Union) country to accept the drug.

Not FDA Approved

Iluvien is not approved for use in the United States.  Most recently, the FDA was not satisfied with the safety data presented by Alimera Sciences, Inc. and recommended additional clinical trials.

What Does This Mean?

Treatment of macular edema from diabetes is difficult and can be frustrating.  Intraocular injections have been a great alternative to the gold standard of laser treatment.

Laser treatment for diabetic macular edema is not appropriate for all patients and alternative treatments are needed.

Ozurdex, a product similar to Iluvien, is FDA approved but not for diabetic macular edema yet has been used “off label.”

 

 

 

 

 

 

Categories
Diabetic retinopathy Treatments

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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