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RIDE/RISE Extension Studies Demonstrate Sustained Visual Gains in DME Patients
Vision gains achieved at the conclusion of the RIDE/RISE studies were maintained in patients with diabetic macular edema who were enrolled in a 2-year open-label extension study, Michael S. Ip, MD, told colleagues at Retina 2015. Improvements in retinopathy level were also sustained.
After 3 years in RIDE/RISE, 500 participants entered an open-label extension in which ranibizumab 0.5 mg (Lucentis) was given as needed in all three treatment arms according to re-treatment criteria. Mean follow-up time was 14.1 months, less than the anticipated 24 months due to the approval of ranibizumab for DME.
One “pitfall” in the analysis is that diabetic retinopathy severity was not a criterion for re-treatment, Ip said.
“With respect to visual acuity, it’s well known that we’re paying the price by waiting [to treat],” Ip said. In RIDE/RISE, patients with DME were randomized to one group of sham treatment or to one of two ranibizumab groups for the first 24 months.
“The group that was treated with sham for 2 years didn’t quite catch up to the groups that were treated initially with ranibizumab, and this remained the case throughout the open-label with PRN follow-on,” Ip said. “Another way to look at this is, with respect to visual acuity, all three groups in the open-label extension maintained their vision with PRN follow-on. They didn’t lose vision.”
Furthermore, fewer injections were given later in the study, with an annualized mean of only 3.8 injections in the extension study.
“Many of the injections were up front, in years 1, 2 and 3, and number of injections decreased in subsequent years,” Ip said.
Regarding diabetic retinopathy severity, levels were maintained from month 24 to month 36, and then to the end of the extension study.
“The two ranibizumab groups had a much higher proportion of patients with a 2- or 3-step or more regression in diabetic retinopathy level. This remained the case to the end of the open-label extension, despite PRN therapy and a mean of 3.8 annualized injections,” Ip said.
Ocular and systemic events differed little between the extension period and the end of the RIDE/RISE studies.