Efficacy and Safety of Ranibizumab vs. Dexamethasone for CRVO
American Journal of Ophthalmology, September 2016
In a phase 3b study known as COMRADE-C, Hoerauf et al. compared ranibizumab injections versus a dexamethasone implant in patients with central retinal vein occlusion (CRVO). They found that although outcomes were similar between the groups in months 1 and 2, ranibizumab maintained better efficacy in months 3 through 6.
This randomized doubled-masked trial included 243 patients (of whom 185 completed the study) who had visual impairment from macular edema secondary to CRVO; baseline best-corrected visual acuity (BCVA) was 20/40-20/400. Patients were randomized 1:1 to receive 1 of 2 regimens: 3 monthly injections of ranibizumab 0.5 mg, followed by as-needed (PRN) injections; or implantation of a sustained-release 0.7-mg dexamethasone device. The primary objective was to compare change in BCVA from baseline to months 1 through 6 for these treatments; secondary, exploratory objectives included changes in central retinal thickness, intraocular pressure, and health-related quality of life.
No difference was observed in BCVA between ranibizumab and dexamethasone at months 1 and 2, but from months 3 to 6, there was significant difference in BCVA gains in favor of ranibizumab. At month 6, mean average BCVA gain was significantly higher with ranibizumab than with dexamethasone (12.86 vs. 2.96 letters; difference of 9.91 letters, 95% CI, 6.51-13.30, p < .0001). At month 6, 58.9% of ranibizumab patients had gained >15 letters versus 18.5% of the dexamethasone patients (p < .0001). Ocular adverse events were reported in 86.6% of the dexamethasone group patients, compared with 55.6% in the ranibizumab group. Patients in the ranibizumab group received a mean of 4.52 injections, including the 3 mandatory initial injections.
The authors stated that the major limitation of this study was that the dexamethasone group received active treatment only once during the 6-month period, based on European labeling, while the ranibizumab patients received treatment PRN. The authors concluded that a single implant of dexamethasone 0.7 was not adequate to maintain efficacy over 6 months, while PRN ranibizumab showed continuing efficacy. A phase 4 study will be conducted to assess longer-term outcomes and different retreatment criteria.
The original article can be found here.