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    Ranibizumab proves instrumental for DME patients in RIDE, RISE trials

    Provided improved visual acuity, diabetic retinopathy remained stable over the long-term

     

    Road to a better way

    The RISE and RIDE Studies were designed to bring DME treatment to the next level and also to some additional questions: Can proliferative DR (PDR) be delayed or prevented, the need for PRP delayed, the debilitating side effects of PRP eliminated, and DR reversed? The answers to all those may be “Yes.”

    Patients in the RISE and RIDE Studies were randomly assigned to 0.3- or 0.5-mg monthly injections of ranibizumab or sham injections. At month 24, patients in the sham group were allowed to cross over to monthly 0.5-mg ranibizumab injections through month 36.

    Dr. Elman explained that 15.4% to 19.7% of patients who were initially randomly assigned to 0.3-mg injections—the dose approved by the FDA—had a clinically significant two-step improvement in the Early Treatment Diabetic Retinopathy Study (ETDRS) severity level as early as month 3 compared with 1.7% to 3.2% in the sham arms (p <0.01), Dr. Elman noted. This improvement continued and stabilized at 18 months in 36.8% to 39.3% of patients.

    An example of such a two-step improvement, i.e., from an ETDRS score of 61 to a score of 47, is provided in Figure 1. A proportion of patients (5.1% to 9.4%) also had an improvement of three or more steps that was significant at 12 months. This improvement continued through 36 months in 14.5% to 15.4% of patients.

    At the 36-month time point, the patients could enter an open-label extension of the study and receive 0.5-mg injections of ranibizumab as needed based on vision and retinal thickness stability.

    Overall, 500 patients entered the open-label extension phase of RIDE and RISE. These patients were followed for a mean of 14.1 months and received a mean of 3.8 annualized ranibizumab injections.

    “Nearly 20% of patients in the open-label extension study did not require any further treatment,” Dr. Elman, said. “Of 298 patients followed for 1 year or longer in this arm, 19.5% did not need further treatment.

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