Effect of Adding Dexamethasone to Continued Ranibizumab Treatment in Patients With Persistent Diabetic Macular Edema: A DRCR Network Phase 2 Randomized Clinical Trial
Maturi RK, Glassman AR, Liu D, et al; Diabetic Retinopathy Clinical Research Network JAMA Ophthalmol. 2018;136:29-38.
Study Summary
The Diabetic Retinopathy Clinical Research Network conducted a phase 2, multicenter, randomized, prospective clinical trial examining the effects of adding intravitreal dexamethasone to ranibizumab in 116 patients (129 eyes) with refractory diabetic macular edema (DME).
The study's primary and secondary endpoints were mean change in visual acuity and central subfield thickness (CST), respectively, at 24 weeks. All patients had to have persistent DME, for which they received at least three intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections in the 20 weeks prior to study inclusion. Researchers initially only included pseudophakic eyes, but due to a slow enrollment phase, the study was opened to phakic eyes as well.
All patients underwent a run-in phase consisting of three monthly injections of ranibizumab. If the DME persisted after this, patients were then enrolled and randomly assigned to either ranibizumab 0.3 mg plus sham injection or to ranibizumab 0.3 mg plus intravitreal dexamethasone 700 ųg.
At the study's beginning, all eyes received ranibizumab and then a sham or dexamethasone injection within 8 days. Each patient was then evaluated at 4-week intervals through week 24. At weeks 4 and 8, all patients received ranibizumab.
