The LuceDex prospective randomized pilot trial compared the combination of intravitreal ranibizumab and dexamethasone with ranibizumab monotherapy for treatment of neovascular age-related macular degeneration.
Thirty-seven eyes of 37 patients were randomized 1:1 between combination therapy with intravitreal ranibizumab and dexamethasone (Group 1) and intravitreal ranibizumab monotherapy (Group 2). All study eyes received 4 monthly treatments followed by monthly treatment on indication.
In the LuceDex study, eyes gained an average of 11.1 and 5.9 Early Treatment of Diabetic Retinopathy Study letters in Groups 1 and 2, respectively, at Month 12. No more than zero Early Treatment of Diabetic Retinopathy Study letters were lost in 88% of Group 1 eyes and 70% of Group 2 eyes. The average number of treatments per study eye by Month 12 was 7.1 in Group 1 and 6.6 in Group 2. Choroidal neovascular membrane size decreased in Group 1 significantly compared with Group 2 (P < 0.05).
The LuceDex pilot study suggested a possible benefit of adding intravitreal dexamethasone to treatment of neovascular age-related macular degeneration with intravitreal ranibizumab. A larger study is needed to further identify and define possible benefits of this combination therapy.