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Improvements with as-needed ranibizumab persist in diabetic retinopathy patients

Stephen Padilla
02 May 2019

Ranibizumab-related improvements in diabetic retinopathy (DR) severity continue in >70 percent of patients in the open-label extension (OLE) of the RIDE and RISE studies after switching from ranibizumab monthly to an individualized ranibizumab 0.5 mg pro re nata (PRN) dosing regimen.

“Because approximately one-third of OLE patients experienced DR worsening, careful monitoring should be part of the long-term management of patients with DR,” researchers said.

In RIDE and RISE, 759 patients were randomly assigned 1:1:1 to ranibizumab 0.3 mg monthly, 0.5 mg monthly or monthly sham injections with rescue macular laser available after 6 months, per protocol-specified criteria. Sham patients shifted to ranibizumab 0.5 mg monthly after 24 months.

In the core studies, OLE patients (n=500) could receive ranibizumab 0.5 mg PRN after 36 months based on predefined diabetic macular oedema (DME) retreatment criteria. The Early Treatment Diabetic Retinopathy Study DR severity scale was used to assess DR severity.

Of the patients who entered the OLE, 121 (24 percent) did not require additional ranibizumab injections. A total of 367 patients had evaluable DR at months 36 and 48. [Ophthalmology 2019;126:712-720]

Among those who did not need ranibizumab retreatment from months 36–48, 57–78 percent experienced DR severity stability, 0–7 percent had 2-step or more improvement, and 22–36 percent had 2-step or more worsening. Of the patients requiring ranibizumab retreatment, 84–94 percent experienced DR severity stability, 2 percent had 2-step or more improvement, and 3–14 percent had 2-step or more worsening.

Regardless of change in DR severity, vision improvement generally persisted during the OLE.

According to researchers, eyes that did not receive any DME criteria-based retreatment over the course of the OLE were more likely to show worsened DR severity.

Worsening of even a single step was associated with increased risk for future sight-threatening complications such as proliferative (P)DR and DME. On the other hand, DR severity improvements could lead to reduced risk of vision-threatening complications. [Invest Ophthalmol Vis Sci 2008;49:5041-5047; Arch Ophthalmol 2001;119:547-553]

“Robust DR improvements with monthly ranibizumab in RIDE and RISE, which can be maintained in many patients with less than monthly dosing, further suggest the possibility of a paradigm shift in DR treatment, with a focus on early treatment to improve DR severity to prevent vision-threatening complications such as PDR or DME, rather than a wait-and-watch approach followed by treatment only for advanced diabetic eye disease complications,” researchers said.

Currently, prospective, randomized controlled trials are being conducted to further understand if antivascular endothelial growth factor (anti-VEGF) treatment of eyes with non-PDR without DME provides future anatomic and visual benefits, they added.

“Future studies also are warranted to provide more information about less than monthly anti-VEGF treatment regimens, to explore additional functional and imaging endpoints in DR, and to evaluate biomarkers to prospectively identify those patients with non-PDR whose disease is most likely to progress to PDR,” researchers said.

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