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Allen C Ho, Jiameng Zhang, Jason S Ehrlich; Ranibizumab for Diabetic Macular Edema: Long-Term Open-Label Extension of the Phase III RIDE and RISE Trials. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1704.
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The RIDE and RISE Phase III studies established the efficacy and safety of up to 3 years treatment with monthly ranibizumab (RBZ) in patients with diabetic macular edema (DME). In the open-label extension phase of these studies we evaluated if the efficacy and safety achieved with monthly RBZ was maintained with less-than-monthly treatment using a protocol-based regimen that allowed for more flexible dosing and visit intervals.
In the core studies, patients with DME (n=759) were randomized to monthly 0.5 mg or 0.3 mg RBZ injected intravitreally or sham injection for 2 years. In year 3, patients in the sham group were eligible for crossover to monthly 0.5 mg RBZ. After month 36, patients (n=500) who enrolled in the optional extension received open-label 0.5 mg RBZ regardless of prior randomization. Treatment was criteria-based: patients received RBZ only if experiencing a ≥5 letter decrease in visual acuity (VA) from Month 36, or if DME was observed on OCT. The visit interval could be extended from 30 days to 60 or 90 days for patients who did not require treatment based on these criteria.
Overall, VA outcomes were excellent, with VA gains achieved after 36 or 12 months of monthly RBZ maintained using less than monthly dosing. Patients initially randomized to sham therapy never achieved the same VA gains as those initially randomized to RBZ. An average of 4.5 injections were administered over a mean 14.1 months follow-up, with <10% of patients continuing monthly RBZ. ~25% of patients did not require further RBZ treatment to maintain VA. Of the ~75% who received additional treatment, vision outcomes were also maintained. The types and incidence of ocular and non-ocular adverse events in the extension phase appeared generally similar to the known safety profile of ranibizumab as observed in the core DME studies.
The RIDE and RISE extension studies demonstrate the long-term durability of ranibizumab’s efficacy in DME. In roughly 25% of patients, no further treatment was required to maintain mean VA outcomes achieved at the exit of the 3 year core studies. In those requiring further treatment, these data demonstrate that less-than-monthly treatment can be sufficient to maintain vision for the majority of patients. The safety profile of RBZ appeared similar to that observed in the controlled core studies.
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