01 Mar Eyelea Improves Vision Faster In Eyes With Worse Diabetic Macular Edema
MedicalResearch.com Interview with:
Adam Glassman
Adam Glassman, M.S.
Director, DRCRnet Coordinating Center
Jaeb Center for Health Research
Tampa, FL 33647
Medical Research: What is the background for this study? What are the main findings?
Response: Diabetic macular edema (DME) involves a build-up of blood and fluid in the macula, the part of the eye needed for sharp, straight-ahead vision. Diabetic macular edema can occur in people with diabetic retinopathy and is the most common cause of diabetes-related vision loss. Anti-VEGF agents are the first line treatment for most U.S. retinal specialists to treat vision loss from DME. There are three commonly used agents to treat DME, EYLEA, Avastin, and Lucentis. Eylea and Lucentis are FDA approved for Diabetic macular edema treatment. However, Avastin is used off-label in repacked aliquots containing approximately 1/500th of the systemic dose used in cancer therapy. The costs of these agents vary substantially, with Eylea priced at $1,850 per injection, Lucentis at $1,170, and repackaged Avastin at $60. Results of this study, conducted by the Diabetic Retinopathy Clinical Research Network (DRCR.net) and funded by the NIH, found that all three agents are effective at improving vision and reducing DME over 2 years. When vision loss is relatively mild at baseline (20/32-20/40), all three agents are similarly effective at improving visual acuity. However, when vision loss at baseline is worse, Eylea outperforms Avastin at 2-years and also outperforms Lucentis at one year, but the difference between Eylea and Lucentis diminishes and is no longer statistically different at 2 years. The percentage of participants that experienced a systemic adverse events such as heart attack, stroke, or death from an unknown cause was greater with Lucentis (12%) versus Eylea (5%) and Avastin (8%). However, similar findings have not been seen in most previous studies.
Medical Research: What should clinicians and patients take away from your report?
Response: The main message for clinicians and patients is that all 3 agents are effective treatments for eyes with vision loss from center-involved Diabetic macular edema. On average, clinicians should expect to see vision improvements by using any one of the three treatments. It is important to note that the vision gains seen at one year were maintained in year two even with about half as many injections and fewer laser treatment. In eyes with mild vision loss, the 3 agents improved vision similarly on average, although Avastin reduces the edema less than the other 2 agents. In eyes with worse baseline vision, Eylea improves vision more than the other 2 agents through one year. By the 2-year endpoint, Eylea is no longer superior to Lucentis but remains superior to Avastin in terms of mean gains in vision. Finally, the higher APTC event rate in the ranibizumab group is inconsistent with prior evidence and should be viewed with caution.
Medical Research: What recommendations do you have for future research as a result of this study?
Response: We are interested to know why DME sometimes persists in some eyes even with anti-VEGF therapy. In addition, the higher rates of heart attack, stroke, and death from cardiovascular conditions or unknown causes with Lucentis warrants continued evaluation in future trials.
Medical Research: Is there anything else you would like to add?
Response: The results from this study will help clinicians and patients make decision on how to manage DME. However, ultimately the decision of which agent to use is going to be based on a number of factors, including cost and insurance coverage.
Citation:
Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema
Wells, John A. et al. Ophthalmology , Volume 0 , Issue 0 ,
DOI: http://dx.doi.org/10.1016/j.ophtha.2016.02.022
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Adam Glassman, M.S. (2016). Eyelea Improves Vision Faster In Eyes With Worse Diabetic Macular Edema MedicalResearch.com
Last Updated on March 1, 2016 by Marie Benz MD FAAD