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Sara J. Haug, Beiying Ding, Na Lu, Ivaylo Stoilov; Ranibizumab for DME following laser and/or steroid treatments: a RIDE/RISE subanalysis. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1759.
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© ARVO (1962-2015); The Authors (2016-present)
To determine if prior laser and/or steroid therapies impacted the visual acuity gains and retinal thickness reduction in patients with DME treated with intravitreal ranibizumab (RBZ) injections in the phase 3 RIDE and RISE trials.
RIDE/RISE enrolled 759 patients with DME who were randomized 1:1:1 to receive monthly RBZ (0.3 mg or 0.5 mg) or sham injections. For this analysis, patients were grouped by prior treatment (ocular/subtenon steroids, macular laser, or panretinal photocoagulation [PRP]). Groupings were: no prior laser or steroid (treatment naive), macular laser or PRP but not steroids (laser only), and both laser and steroid (laser + steroid).
Prior laser and/or steroid treatment was received by 76% of patients (laser only, n=346; laser + steroid, n=218; Figure 1). Only 24% of RIDE/RISE patients (n=181) were treatment naive at baseline. The number of patients within each group was similar across treatment arms. Mean baseline BCVA was, on average, worse in the prior laser + steroid group and better in the treatment-naive group (Table 1). Among patients receiving RBZ, the mean increase in BCVA at month 24 was similar regardless of prior treatment. Mean baseline macular edema as measured by central foveal thickness (CFT) was, on average, highest in the prior laser + steroid group (mean, 505.1 μm) and lowest in the prior laser only group (mean, 441.4 μm). Ranibizumab treatment produced clinically significant reduction in edema regardless of previous treatment status, with mean change from baseline at month 24 ranging from −241.6 to −290.5 μm across subgroups, compared with −122.4 to −146.9 μm for sham.
The RIDE/RISE patient population represented a wide range of clinical DME phenotypes including a large proportion of “difficult to treat patients” who had persistent DME despite receiving laser and/or steroid therapies. Patients receiving RBZ had comparable improvements in vision and resolution of edema at month 24 regardless of prior treatment, suggesting that RBZ is effective in both treatment-naive and patients previously treated with laser and/or steroid therapies.
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