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Protocol U: No overall difference between single, combined treatments
NEW ORLEANS — No overall difference was found in mean visual acuity gains in patients treated with Lucentis alone or with Lucentis plus dexamethasone, according to a speaker.
“We wanted to evaluate if a combination treatment would be superior to anti-VEGF treatment alone for patients with persistent edema,” Raj K. Maturi, MD, said at Retina Subspecialty Day preceding the American Academy of Ophthalmology meeting, where he delivered results of the Diabetic Retinopathy Clinical Research Network Protocol U trial.
“We enrolled 236 eyes, gave them three injections of ranibizumab (Lucentis, Genentech), and those who continued to have edema and vision loss were randomized into two arms. The combination arm included dexamethasone and ranibizumab, with ranibizumab given monthly and dexamethasone being able to be given a second time as early as 12 weeks later. The other arm just included ranibizumab every 4 weeks,” Maturi said.
Mean change in visual acuity at 24 weeks was the endpoint, while the secondary endpoint was the change in central subfield thickness as seen on OCT at 24 weeks.
At the end of 24 weeks, the ranibizumab arm improved in vision by an additional three letters, and the combination arm improved similarly, he said.
On average there was a greater reduction in retinal thickness in the dexamethasone plus ranibizumab group.
The study was not sufficiently sized to determine whether treatment response might differ by lens status, he said. – by Patricia Nale, ELS
Reference:
Maturi RK. Protocol U: Short-term evaluation of combination dexamethasone + ranibizumab vs. ranibizumab alone for persistent central-involved DME following anti-VEGF therapy. Presented at AAO Subspecialty Days; Nov. 10-11, 2017; New Orleans.
Disclosure: Maturi reports being a paid consultant for Allergan and Genentech/Roche.