Long-term use of Lucentis (ranibizumab) looks safe….
Lucentis (ranibizumab) is an as-needed injection for diabetic macular edema (DME). In preliminary results, researchers found that after 3 total years, Lucentis use showed no significant difference in ocular or non-ocular adverse events. This is regardless of whether the patients initially had injections of the medication or laser surgery.
Gabriele Lang, MD, of the University Eye Hospital in Ulm, Germany, and colleagues reported these findings at the annual European Association for the Study of Diabetes (EASD) meeting. The study was a 2-year, open-label extension to the year-long, randomized, controlled RESTORE trial.
Improvements that were seen at the end of the 12 months of the RESTORE trial "were maintained during the 24-month extension study in patients initially treated with ranibizumab, and improved in patients initially treated with laser in the core study and subsequently treated with ranibizumab in the extension study," Lang stated at the meeting.
The extension study was broken up into 2 phases. In the first phase, patients were randomized to one of three groups: Lucentis alone (with a fake laser procedure), Lucentis plus a real laser procedure or laser procedure alone (plus fake injections). Then in the second phase, all the patients were placed on as-needed Lucentis. 240 patients were enrolled into the second phase with 181 patients completing all 3 years of the study.
The mean number of injections during Lang’s extension study was approximately 6-7 in all three groups with a gradual decline over the course of the study, ending with the majority of patients only needing 2-3 injections during the third year. It was noted that 19-25% of patients from all 3 groups combined did not require any Lucentis injections during the extension study.
In the end, Lang and colleagues did not observe any significant differences in ocular or non-ocular events across groups. Across all groups, 50-60% of patients experienced an ocular event (mainly eye pain and cataract) and 73% experienced a non-ocular event (typically nasopharyngitis), the research team reported. Over the course of the 3-year combined studies, no incidence of endophthalmitis, retinal tear, or retinal detachment was reported.
Visual acuity improvements were preserved in those who received Lucentis injections during the RESTORE trial, and those who received only laser surgery had significant improvements during the follow-up phase. The mean best-corrected visual acuity witnessed was at 3 years in the Lucentis alone group, with an increase of approximately 8 letters. The combination laser surgery and Lucentis group was maintained at 6.7 letters, while the surgery-only group had an increase of 2.3 letters at one year to 6 letters by the end of year 3. It was noted that central retinal thickness values homogenized at 3 years when all patient groups were receiving Lucentis.
It was concluded that the data and findings from the study show that Lucentis use over 3 years has maintained its safety profile because "no new ocular or non-ocular safety findings or increased safety concerns." Lang and her colleagues concluded.