Take-home: Earlier treatment of patients with DME who have had visual acuity loss results in the need for fewer intravitreal injections of ranibizumab over the long term.
Reviewed by Charles C. Wykoff, MD, PhD
Houston—Early administration of anti-vascular endothelial growth factor (VEGF) treatment, specifically ranibizumab (Lucentis, Genentech), in patients with diabetic macular edema (DME) and decreased visual acuity (VA) was shown to be beneficial in this population. Early initial intervention with ranibizumab showed that these patients who had better baseline VA responded well to treatment and needed fewer intravitreal injections over the long term.
This was an important finding of the RIDE/RISE open-label extension trial. The authors, led by Charles Wykoff, MD, PhD, reported their results in Ophthalmology
Identifying clinical markers is important because they may allow some degree of prognostication for the patients’ clinical course and treatment burden, according to Dr. Wykoff.
“The objective of this analysis was to characterize those patients who required less re-treatment during the open-label extension (OLE),” the authors commented.
The 500 patients included in the OLE were participants in the RIDE/RISE studies. The patients randomized to sham treatment in the RIDE/RISE studies began to receive monthly 0.5-mg injections of ranibizumab at month 25 and those who initially were randomized to ranibizumab continued to receive either 0.3- or 0.5-mg injections of ranibizumab as originally assigned out to 36 months. Upon entering into the OLE, all patients could receive as-needed injections of 0.5-mg of ranibizumab when DME was detected on optical coherence tomography (OCT) images or when there was a decrease in the best-corrected VA (BCVA) of five or more Early Treatment of Diabetic Retinopathy Study letters.
During the OLE portion of the study, the authors evaluated the effect of the patients’ baseline data, disease characteristics, and treatment response to ranibizumab during the RIDE/RISE studies in an effort to predict how frequently patients with DME would need long-term treatment.
Dr. Wykoff, who is in private practice in Houston, reported about half of the patients required no or fewer than four annualized injections (121 required zero; 132 required one to three). Of the remainder of the patients, 159 required four to seven annualized injections and 88 needed more than seven annualized injections.
The parameters significantly associated with the number of injections required during the OLE were the number of rescue focal macular laser applications administered during the core studies, the baseline and month 36 central foveal thickness, the area of fluorescein leakage at month 36, and the hemogloblin A1c levels at month 36.
When the investigators compared the characteristics of the 121 patients who did not need injections to the 88 patients who needed more than seven injections during the OLE, the severity of disease and response to treatment were strong predicting factors.
Patients requiring no re-treatment had a shorter duration of diabetes and DME at baseline, were less likely to have proliferative diabetic retinopathy at baseline, received fewer rescue focal macular laser treatments, and were more likely to experience diabetic retinopathy severity scale improvements, Dr. Wykoff reported.
The percentage of patients with proliferative diabetic retinopathy at baseline was lower with those who did not require injections during the OLE study (27.3%), than with patients who needed more than seven injections (47.7%). Importantly, those patients who did not need injections during the OLE study, “were more likely to experience a ≥ 2-step improvement of the Diabetic Retinopathy Severity Scale at months 24 and 36 (21.5% and 33.9%, respectively) compared with the patients requiring >7 annualized injections (12.5% and 17.0%, respectively),” according to the investigators.
The conclusion from the study seems to be that earlier anti-VEGF treatment in patients with DME that has caused a decrease in VA results in better VA and anatomic outcomes.
Charles C. Wykoff, MD, PhD
E: [email protected]
Dr. Wykoff is a consultant for Genentech and has received research supporting grants from the company.