Study tracks clinical use of dexamethasone implant for DME
REINFORCE study vision gains and no new safety concerns
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.