Diabetic Macular Edema Study Leads to Approval of New Drug Treatment

Diabetic macular edema is swelling of the nerve tissue in the retina due to leaky retinal blood vessels from diabetic damage. When this involves the part of the retina that provides central vision, driving vision and reading vision are lost. A new treatment recently was approved in the USA for diabetic macular edema based on the results of a pivotal phase III trial for diabetic macular edema. The doctors of the Hawaii Macula and Retina Institute were Hawaii’s only center in the VISTA trial. This trial led to the approval of Eylea for diabetic macular edema by the FDA (Federal Drug Advisory Board) in July of 2014.

Dr. Gregg Kokame, the principal investigator of this study, and director of the Hawaii Macula and Retina Institute, reports that the VISTA study showed that eyes receiving Eylea had a much higher chance of improved vision that the control group receiving laser photocoagulation at the primary endpoint of 52 weeks. The monthly 2 mg Eylea intravitreal injection group showed a 3 line or more vision gain in 41.6% of eyes. The every other month 2 mg Eylea group showed a 3 line or more vision gain in 31.1% of eyes. The standard of care laser group showed a 3 line or more vision gain in only 7.8% of eyes. Very significantly, recent results showed that these gains were sustained at 100 weeks. These results were confirmed by a similar trial called the VIVID trial utilizing international study sites.

Dr. Kokame has been the principal investigator in trials leading to the approval of Lucentis for wet macular degeneration (MARINA trial), Lucentis for diabetic macular edema (RISE trial), and Eylea for exudative macular degeneration (VIEW 1 study). One of the goals of our research center is to provide the most promising new therapies to our patients in Hawaii, that often cannot be obtained outside of clinical trials

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