Long-term stability of ranibizumab shown in DME patients

May 6, 2014

In roughly 25% of patients, no further treatment was required to maintain mean visual acuity (VA) outcomes achieved at the exit of the RIDE/RISE 3-year core studies evaluating the efficacy of ranibizumab in patients with diabetic macular edema (DME), according to Allen Ho, MD.

Orlando-In roughly 25% of patients, no further treatment was required to maintain mean visual acuity outcomes achieved at the exit of the RIDE/RISE 3-year core studies evaluating the efficacy of ranibizumab in patients with diabetic macular edema (DME), according to Allen Ho, MD.

The open-label extension phase of the studies evaluated whether the efficacy and safety achieved with monthly ranibizumab was maintained with less-than-monthly treatment using a protocol-based regimen that allowed for more flexible dosing and visit intervals, said Dr. Ho, Wills Eye Institute, Philadelphia.

In the core studies, patients with DME (n = 759) were randomly assigned to monthly 0.5 or 0.3 mg ranibizumab injected intravitreally or sham injection for 2 years. At that point, those in the sham group could cross over to receive active dosing. After month 36, patients (n = 500) who enrolled in the optional extension received open-label 0.5 mg ranibizumab regardless of prior randomization and to date, results are through month 54.

“Overall, visual acuity outcomes were excellent, with visual gains gains achieved after 36 or 12 months of monthly ranibizumab maintained using less-than-monthly dosing,” Dr. Ho said.

 

In terms of re-treatment, 26.7% of patients in the sham/0.5-mg arm, 24.4% of patients in the 0.3-mg arm, and 21.5% of patients in the 0.5-mg arm required no additional treatment.

There were no new adverse events (AEs) or serious AEs noted in the open-label portion, he said.

“If you’re treating consistently early enough, you can change the course of DME and you can induce regression,” Dr. Ho said. “Moving from three loading doses to PRN may be leaving some potential vision gains on the table.”

 

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