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Masahito Ohji, Tatsuro Ishibashi, Sr., REVEAL study group; Efficacy And Safety Of Ranibizumab 0.5 Mg As Monotherapy Or Adjunctive To Laser Versus Laser Monotherapy In Asian Patients With Visual Impairment Due To Diabetic Macular Edema: 12-month Results Of The REVEAL Study. Invest. Ophthalmol. Vis. Sci. 2012;53(14):4664.
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Compare efficacy and safety of ranibizumab 0.5 mg (RBZ) as monotherapy or adjunctive to laser versus laser monotherapy in Asian patients with visual impairment (VI) due to diabetic macular edema (DME).
Randomized, double-masked, multicenter Phase III study (www.clinicaltrials.gov NCT00989989) in 396 DME patients treated with either RBZ+sham laser (n=133), RBZ+active laser (n=132), or sham injection+active laser (n=131) for 12 months (M). RBZ/sham injections were given on Day 1, M1, M2, and pro-re-nata thereafter based on best-corrected visual acuity (BCVA, measured by ETDRS chart) stability and DME progression. Active/sham laser photocoagulation was performed according to ETDRS guidelines at ≥3 month intervals. Key evaluation parameters: mean average change in BCVA from baseline to M1-M12 (primary endpoint), mean change from baseline to M12 in BCVA and central retinal thickness (CRT, assessed by optical coherence tomography), 12M incidence of ocular and non-ocular adverse events (AEs).
345 (87.1%) patients completed the study. Baseline mean values: 61.1 years of age, 98.7% patients with type II diabetes, 7.5% HbA1c, 58.6 letters BCVA, 421.9 µm CRT. Primary endpoint (RBZ/RBZ+laser versus laser): +5.9/+5.7 letters versus +1.4 letter (both P<0.0001). Mean BCVA and CRT change from baseline to M12 (RBZ/RBZ+laser versus laser): +6.6/+6.4 letters versus +1.8 letter and -148.0/-163.8 µm versus -57.1 µm, respectively (P<0.0001). Mean number of treatments (RBZ/RBZ+laser/laser): 7.8/7.0/7.4 RBZ/sham injections, 1.5/1.5/1.9 active/sham laser. Main AEs (RBZ/RBZ+laser/laser): conjunctival hemorrhage (12.8/9.1/5.5%), nasopharyngitis (7.5/7.6/6.3%). Serious AEs were reported for 15.8% (RBZ), 16.7% (RBZ+laser), and 14.8% (laser), 1 patient died in a fatal car accident (unrelated to study treatment, RBZ arm).
RBZ as monotherapy or adjunctive to laser provided significantly superior BCVA and CRT improvements over laser therapy. The safety outcome is consistent with the established safety profile of RBZ. REVEAL confirms in Asian patients with VI due to DME the efficacy and safety results of the RESTORE study.
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