Study tracks clinical use of dexamethasone implant for DME

Take home: A 6-month analysis from the REINFORCE study of the dexamethasone intravitreal implant Ozurdex found an average of one- to two-line vision gains and no new safety concerns.

NEW BRUNSWICK, NEW JERSEY-A dexamethasone intravitreal implant (Ozurdex, Allergan) was associated with one- to two-line vision gains on average in patients with diabetic macular edema (DME) in the phase IV REINFORCE study, said Howard F. Fine, MD, MHSc, clinical associate professor, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey.

The implant has been approved by the U.S. Food and Drug Administration for macular edema secondary to retinal vein occlusion and noninfectious uveitis, Dr. Fine said. It also was approved for DME after positive results from the phase III MEAD study.

The prospective, multicenter, observational registry REINFORCE study-short for Real-World Assessment of Dexamethasone Inravitreal Implant in Diabetic Macular Edema-measured real-world outcomes of the implant when used to treat DME, Dr. Fine said. The data presented were an interim analysis of the 1-year study of 101 study eyes (94 patients) that had completed at least 6 months of follow-up.

The implant was used as adjunctive or monotherapy in patients, all of whom had DME. Eighty-eight patients (93.6%) were previously treated prior to the first dexamethasone injection. The mean DME duration was more than 1 year in 73 eyes (72.3%) and more than 2 years in 51 eyes (50.5%). In 63 eyes (62.4%), the injection was used as monotherapy.

The mean injection frequency was 1.5, and the mean reinjection interval in patients receiving multiple implants was 135.4 days, according to the study abstract.

Mean peak improvement

“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: hffine@gmail.com

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.