Purpose: To examine diabetic retinopathy (DR) outcomes in patients (pts) at high risk for negative outcomes using data from RIDE/RISE and Protocol S. In RIDE/RISE, pts with moderately severe to severe nonproliferative DR (NPDR) at baseline were assessed due to their high risk for progression to proliferative disease (ETDRS Report 12. Ophthalmology. 1991). In Protocol S, the majority of pts had proliferative DR (PDR) at baseline, which is associated with vision loss (Moss. Ophthalmology. 1998), and DR outcomes were assessed according to diabetic macular edema (DME) status at baseline.
Methods: In the randomized phase 3 RIDE (NCT00473382)/RISE (NCT00473330) studies, pts with DME (N = 759) received monthly ranibizumab (RBZ) (0.3 mg or 0.5 mg) or sham treatment through the month (M) 24 primary end point. In the randomized phase 3 Protocol S (NCT01489189) study, eyes with and without DME received either prompt pan-retinal photocoagulation or RBZ 0.5 mg (as needed after 3 monthly treatments) (N = 394 eyes). M24 DR outcomes are retrospectively evaluated herein.
Results: In RIDE/RISE, ∼ 30% of pts in each arm had high-risk NPDR at baseline (DR severity level 47/53) (35.9%, 30.0%, and 33.9% for RBZ 0.3 mg, RBZ 0.5 mg, and sham, respectively). A significant majority of these pts (78.4% and 81.1% of RBZ 0.3 mg- and 0.5 mg-treated, respectively) achieved ≥ 2-step DR improvement at M24 vs. only 11.6% of sham-treated pts (P < .0001). Notably, these rates of ≥ 2-step DR improvement with RBZ were more than 2 times higher than the overall population at M24 (37.2% and 35.9% for RBZ 0.3 mg and 0.5 mg, respectively) (Ip. Arch Ophthalmol. 2012). In Protocol S, 87% of eyes had PDR and 22% of eyes had DME at baseline. At M24, RBZ treatment resulted in ≥ 2-step DR improvement in eyes with (58.5%) and without (37.8%) DME at baseline.
Conclusions: RBZ treatment was effective at significantly improving DR in pts at high risk for DR-related vision loss, irrespective of baseline DME status.
V. Hershberger: None. L.F. Hill: Employee; Self; Genentech, Inc. L.L. Tuomi: Employee; Self; Genentech, Inc. A. Ghanekar: Employee; Self; Roche Pharma. Stock/Shareholder; Self; Roche Pharma.