The first round of results has been released from an ongoing study comparing current drug options for treatment of diabetic macular edema (DME). The study showed that all patients had significant improvement in vision with regular treatment with any of the three anti-VEGF drugs. All three drugs were needed, on average, nine times in the first year, though some patients required 12 injections to get the maximum vision improvement.
Overall, there was a slightly better vision outcome in those patients who were taking Eyelea. Eyelea patients had a vision gain of three letters, on average, over those taking Lucentis. This improvement of Eyela over the other two drugs was limited to those patients who already had moderate vision loss. All three drugs performed quite similarly when the vision loss was defined as being mild. The results will help doctors and patients make informed decisions when choosing treatments for DME.
Mild vision loss was classified as a score between 20/32 and 20/40 on a specialized vision chart with a very specific eyeglass correction. In real life, it may mean that your vision on a standardized chart could conceivably be much worse and you may still be classified as a mild vision loss under the definition of the study. Worse vision was considered moderate loss.
The results suggest that the worse the patient's vision is when treatment begins, the more likely it is that treatment with Eylea will have a better result. The study did not identify an absolute cut-off where Eylea was more effective than Avastin or Lucentis.
Because this study was focused only on people who had no, or very little, previous treatment for DME, these results do not suggest that people who are already being successfully treated for DME should change treatments. If you have questions about your treatment, your own ophthalmologist is the best person to discuss your options with.
For the study, 660 people with DME were enrolled at 89 trial sites. Each participant was randomly assigned to receive Eylea, Avastin, or Lucentis in one eye. All three of these drugs are anti-VEGF drugs that block the growth of blood vessels that cause DME. The patients in the study are continuing on the same treatment for one more year, when the study is scheduled to finish. The final results, the two year data, could be published by early 2016.
Other treatments for diabetic macular edema now include the use of laser therapy, and intravitreal steroids. Ozurdex, a dexamethasone implant for diabetic edema that lasts between 3 and 6 months as well as a different steroid drug, Iluvein, that lasts 1.5 to 3 years are now approved for the treatment of diabetic retinopathy.
The study is being conducted by the Diabetic Retinopathy Clinical Research Network and is supported by the United States' National Institutes of Health.
About Diabetic Macular Edema
Diabetic macular edema is a build-up of blood and fluid in the macula and can occur at any stage of diabetic retinopathy. Because the macula is the part of the eye needed for sharp, straight-ahead vision, damage to this area can cause dramatic vision problems. DME is the most common cause of diabetes-related vision loss.
There are currently 29.1 million Americans living with diabetes. Of those, 4.2 million have diabetic retinopathy and 650,000 of those have advanced diabetic retinopathy, such as DME and proliferative diabetic retinopathy. When DME involves the central retina and causes vision loss, most ophthalmologists first treat with anti-VEGF drugs. These drugs are injected into the eye as often as once per month. If DME continues without improvement after six months of anti-VEGF injections, laser surgery is often done.