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    Study tracks clinical use of dexamethasone implant for DME

    REINFORCE study vision gains and no new safety concerns

     

    “The top-line study data are the mean peak improvement from baseline was 8.2 letters following the first [injection] and 8.7 letters following the second injection,” Dr. Fine said. The proportion of 3-line gainers at any follow-up visit was 27.6%, and the reinjection interval was 4.5 months on average.

    “What was most impressive to me is that since this is a real-world study, the majority of patients (93.6%) had received prior treatment for DME, particularly anti-vascular endothelial growth factor injections [VEGF] and/or laser,” Dr. Fine said. “Therefore, this study demonstrates a significant role for [the implant] in patients treated for DME, such as incomplete anti-VEGF responders and those who cannot tolerate a high anti-VEGF injection frequency.”

    Patients’ central retinal thickness improved from baseline each month over the first 6 months after the first injection, with a mean peak change of –122.5 μm from baseline at month 2. IOP increased in 7.2% of eyes; 8.2% had an IOP greater than 25 mm Hg, and 1% had an IOP greater than 35 mm Hg.

    Dr. Fine and fellow investigators concluded that as either monotherapy or combination therapy, patients receiving the dexamethasone intravitreal implant had improved best corrected visual acuity and central retinal thickness, and there were no new safety concerns.

    The 1-year results from REINFORCE should be ready by the end of 2016; Dr. Fine said he is particularly interested in data regarding combination therapy of both anti-VEGF and dexamethasone  injections.

     

    Howard F. Fine, MD, MHSc

    E: [email protected]

     

    This article was adapted from Dr. Fine’s presentation at the 2016 meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Seattle, Washington. Dr. Fine is a consultant for Allergan.

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