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    Study finds no VA benefit by adding corticosteroid implant to anti-VEGF injections

    Results from the Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol U are providing some insights on the management of diabetic macular edema (DME) that does not respond optimally to regular anti-VEGF injections.

    The study found that many patients will benefit from continuing with anti-VEGF treatment using ranibizumab 0.3 mg (Lucentis, Genentech). While the combination therapy with the addition of the sustained, dexamethasone drug-delivery system 0.7 mg (Ozurdex, Allergan) resulted in greater reduction in retinal thickness compared with anti-VEGF monotherapy, it was not associated with any functional benefit and exposed patients to the known corticosteroid-related risks.

    Raj K. Maturi, MD, presented the results at Retina Subspecialty Day 2017 and they were published concurrently in JAMA Ophthalmology.

    “About 40% of patients with DME continue to have retinal thickening and reduced vision despite regular anti-VEGF injections,” said Dr. Maturi, clinical associate professor of ophthalmology, Indiana University School of Medicine; private practice, Midwest Eye Institute, both in Indianapolis. “The results of Protocol U suggest that many of these individuals will improve by continuing the same treatment for another 3 to 6 months.

    “Previous studies have consistently shown that corticosteroids reduce retinal thickening in eyes with DME, and in Protocol U, there was greater reduction in macular thickness when adding the corticosteroid implant to anti-VEGF therapy,” Dr. Maturi added. “That benefit, however, must be balanced by the lack of functional benefit and the high incidence of intraocular pressure (IOP) rise that also occurs with this treatment.”

    Results of a preplanned subgroup analysis of best-corrected visual acuity (BCVA) outcomes based on phakic status suggested that corticosteroid-induced cataractous changes may have limited visual acuity improvement in the combination therapy group. However, Protocol U was not sufficiently sized to determine if pseudophakic patients would have greater functional benefit with combination treatment, Dr. Maturi said.

    “The study was originally designed to enroll only pseudophakic patients, but it was expanded to include phakic eyes because enrollment was very slow,” Dr. Maturi pointed out. “Therefore, we believe it would be difficult to conduct another larger study to investigate any benefit of combination therapy in pseudophakic patients.”



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