Ozurdex monotherapy and adjunctive therapy for DME showed real-world clinical improvement
FORT LAUDERDALE, Fla. — Dexamethasone injections improved vision and dried the macula in real-world practice for patients with diabetic macular edema, according to a speaker here.
“If you look at the real-world practice, [dexamethasone] monotherapy seems to be very good as a primary or adjunctive therapy to increase best corrected visual acuity and decrease central retinal thickness in diabetic macular edema,” Michael A. Singer, MD, said at the inaugural Retina World Congress.
The REINFORCE study is a prospective, multicenter study of Ozurdex (dexamethasone intravitreal implant, Allergan) for the treatment of DME. The study assessed real-world data for outcomes in DME patients receiving dexamethasone as monotherapy or adjunctive therapy. The study included 180 eyes of 177 patients. Primary endpoints were the mean maximum best corrected visual acuity change from baseline following each dexamethasone injection, the percentage of patients with a 15-letter or greater improvement in BCVA and an average improvement in BCVA. The study followed patients for 1 year after their first injection, Singer said.
Thirty-six percent of eyes experienced a 15-letter or greater improvement in BCVA from baseline, and the mean average improvement in BCVA from baseline using the area under the curve approach was 3.6 letters, Singer said.
The mean maximum change in central retinal thickness from baseline was –137.7 µm. Additionally, 19.4% of study eyes achieved a BCVA of 20/40 or better and a central retinal thickness of 300 µm or less, he said.
“What we’ve learned is it lasts about 4 months. The IOP numbers seem to be a little bit better than what they were in the pivotal trials; however, this is real life and a smaller sample size. It seems to perform relatively well. There doesn’t seem to be resistance with multiple injections over time, so you’re able to get the same effect again and again. It also seems to be a good second-line therapy,” Singer said. – by Robert Linnehan
Singer MA. REINFORCE study. Presented at: Retina World Congress; Feb. 23-26, 2017; Fort Lauderdale, Fla.
Disclosure: Singer reports he is a speaker and/or consultant with Allergan, Genentech and Regeneron, and has received research funding from Allegro, Ampio, Neurotech, Ophthotech, Pfizer and Santen. He reported Allergan was a study sponsor.