February 20, 2015

Treatment Options for Diabetic Macular Edema (DME)

Wolfe Eye Clinic Retina Specialists Jared Nielsen, MD, Jeong Sohn, MD, Kyle Alliman, MD and David Saggau, MD recently took part in a national clinical trial supported by the National Institutes of Health*. The study compared three drugs for treatment of Diabetic Macular Edema (DME): Eylea (aflibercept), Avastin (bevacizumab) and Lucentis (ranibizumab). Before we detail the study findings, let's quickly break down the development of DME.

About DME

Diabetic retinopathy is a type of diabetic eye disease that can cause the growth of abnormal blood vessels in the retina. Diabetic Macular Edema or DME can occur in people with diabetic retinopathy. Of the about 7.7-million Americans that have diabetic retinopathy, 750,000 of these individuals have DME. The macula is the area of the retina used when one looks straight ahead for tasks such as reading, driving and watching television. Macular edema is the swelling that occurs when fluid leaks from retinal blood vessels and accumulates in the macula, distorting vision. Macular edema can arise during any stage of diabetic retinopathy and is the most common cause of diabetes-related vision loss.

The Study

660 people with macular edema at 88 clinical trial sites across the United States took part in the study. At the study's start, participants were 61 years old on average, and had had type 1 or type 2 diabetes 17 years on average.

Only people with a visual acuity of 20/32 or worse were eligible to participate. (To see clearly, a person with 20/32 vision would have to be 20 feet away from an object that a person with normal vision could see clearly at 32 feet.) At enrollment, about half the participants had 20/32 or 20/40 vision, and the other half had 20/50 or worse vision.

Each participant was randomly assigned to receive Eylea, Avastin or Lucentis. Participants were evaluated monthly and received the assigned study drug by injection directly into the eye until the DME resolved or stabilized. Additionally, laser treatment was given if DME persisted without continual improvement after six months of injections. Laser treatment alone was the standard treatment for DME until widespread adoption of these drugs a few years ago.


One year after starting treatment, vision had improved substantially for the majority of trial participants. When visual acuity was 20/32 or 20/40 at the start of the trial, vision improved on average almost two lines on an eye chart in all three treatment groups. Eylea provided overall greater visual improvement, on average almost four lines, than did Avastin or Lucentis when vision was 20/50 or worse at the start of the trial.
"This landmark study assists retina specialist to better tailor treatment regimens for our individual patients, allowing them to continue to see and be productive and happy. The study continues to confirm that Avastin, Eylea and Lucentis are all effective medications for our patients with diabetic macular edema, but points out that those with more profound edema may benefit from receiving Eylea." - Jared S. Nielsen, M.D.
To learn more, read the Des Moines Register's article about the retina study.

*The trial was funded by the National Eye Institute (NEI), part of the National Institutes of Health (NIH).

The study was funded by grants EY14231, EY14229, and EY18817.

Eylea and Lucentis were provided by drug manufacturers Regeneron and Genentech, respectively. Additional research funding for this study was provided by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), also a part of the NIH.

The study is registered as NCT01627249 at ClinicalTrials.gov.