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Michael J Elman, Jiameng Zhang, Ivaylo Stoilov; Long-term improvements in vision and diabetic retinopathy achieved and maintained with PRN ranibizumab therapy in the RIDE and RISE trials. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3145.
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To evaluate long-term effects of as-needed (PRN) ranibizumab (RBZ) treatment on vision and diabetic retinopathy (DR) in patients with diabetic macular edema (DME).
In RIDE/RISE, patients were randomized 1:1:1 to monthly RBZ 0.3 mg or 0.5 mg, or sham injections. Sham patients crossed over to monthly RBZ 0.5 mg at Month 24. At Month 36, participants were eligible to enter the open-label extension (OLE) and receive RBZ 0.5 mg PRN according to pre-defined treatment criteria. Descriptive statistics of observed data were provided for efficacy and safety analyses with no imputation of missing data. Best-corrected visual acuity (BCVA) was measured by the ETDRS chart from a 4-m distance. Worsening of DR was comprehensively evaluated in a time-to-event analysis of new proliferative DR (PDR) events using a composite outcome endpoint that included both changes in DR severity on fundus photographs plus the occurrence of clinically significant adverse events or procedures.
500 patients were enrolled in the OLE. Mean follow-up time in the OLE was 14.1 months, with a mean of 3.8 annualized RBZ 0.5 mg injections. Nearly 25% of patients in the OLE did not require any further treatment. Of 298 patients followed for ≥1 year in the OLE, 19.5% required no further therapy. Mean BCVA gains for RBZ 0.3 mg, RBZ 0.5 mg and sham/RBZ 0.5 mg at Month 36 were 12.4, 11.2, and 4.5 letters, respectively. Visual acuity gains achieved with monthly RBZ therapy at Month 36 were maintained with PRN treatment. Patients originally randomized to sham injection never achieved vision gains comparable with patients initially treated with RBZ, indicating that early treatment is important. RBZ-treated patients had a lower risk of developing a new PDR event over time compared with sham crossover patients. At Month 60, improvement in ETDRS DR severity level by ≥2- and ≥3-steps from baseline was observed in up to 40% and 12% of patients, respectively. The occurrence of ocular and systemic serious adverse events was consistent with results of the core studies.
RBZ treatment rapidly achieves improvement in vision and reduces DR severity level by 6 months in patients with baseline DME. These improvements can be maintained long-term with PRN RBZ therapy with approximately 25% of patients requiring no additional treatment during the OLE.
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