RISE and RIDE meet primary endpoints with ranibizumab
MedWire News: Results from two identical phase III trials show that ranizumab is an effective treatment for diabetic macular edema (DME), a common symptom of diabetic retinopathy (DR).
Previous, successful trials of the anti-VEGF antibody fragment ranibizumab led to the methodologically identical RIDE and RISE Phase III trials, the results of which were presented by David Boyer (Retina Vitreous Associates Medical Group, Los Angeles, California, USA) in a late-breaking abstract session at the 71st American Diabetes Association Scientific Sessions in San Diego, USA.
"The data are promising for patients with diabetes because there are currently no FDA-approved medicines to treat this debilitating eye condition," said Boyer.
RIDE and RISE were randomized, multicenter, double-masked trials that took place over 36 months, with the primary endpoint being measured at 24 months during the sham-injection control period.
In RISE, 127 patients were treated with sham injection, 125 with ranibizumab 0.3 mg, and 125 with ranibizumab 0.5 mg once a month. Similarly, RIDE recruited 130, 125, and 127 patients to corresponding groups. The patients were all aged 18 years or above, had diabetes, and had a decrease in vision caused largely by DME.
The primary endpoint of the two trials was for ranibizumab to enable a significantly larger proportion of patients to achieve an improvement of 15 or more letters on the best corrected visual acuity (BCVA) test at month 24, when compared with sham treatment.
This endpoint was achieved in both trials, with 44.8% and 39.2% of the ranibizumab 0.3 and 0.5 mg/month groups in the RISE trial achieving an improvement of 15 or more letters, respectively, compared with 18.1% of the sham group. The respective percentages for the RIDE trial were 33.6% and 45.7% versus 12.3%. Both sets of improvements in both trials were statistically significant compared with sham treatments.
In addition, 54-63% of patients treated with ranibizumab achieved a BCVA Snellen Equivalent of 20/40 vision or better, compared with 35-38% of sham-treated patients.
Boyer noted that contrast sensitivity also improved significantly in ranibizumab- versus sham-treated patients.
Adverse events were minimal, and serious adverse events did not differ significantly between sham- and ranibizumab-treated groups.
Ranizumab treatment has the potential to significantly improve vision in patients with DR and DME, said Boyer.
"There was a rapid and sustained improvement in both vision and retinal anatomy and reduced progression of DR with ranibizumab," he explained.
"This is a potential new standard of treatment in patients with DME and underscores the need for a prompt referral to the ophthalmologist for treatment."
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By Helen Albert