Data from RIDE/RISE Studies Show Better Response to Lucentis in Patients with Less Advanced Disease and Less Frequent Injections

To identify clinical predictors of the long-term burden of treatment in diabetic macular edema (DME) patients whose eyes were injected with the anti-VEGF agent ranibizumab (Lucentis/Roche), a pooled, retrospective, post hoc analysis of data from all phase III, randomized RIDE/RISE studies and their subsequent open-label extension phase was done in the 500 patients who enrolled in the extension phase. Results of the analysis were published in a recent issue of Ophthalmology.

The main outcome measure of the analysis was the association of patient characteristics and responses to treatment during the 36-month RIDE/RISE trials with treatment burden observed during the extension phase of the trials. This criteria-based pro re nata re-treatment phase lasted a mean of 14 months.

During this phase, the mean annualized number of injections was 3.8. However, nearly one-quarter of patients (121, or 24.2%) did not require re-treatment during the extension phase to maintain the anatomic and visual improvements obtained during the core RIDE/RISE trials.

To better characterize patients who required no re-treatment during the extension phase, these patients were compared with patients who needed >7 injections (88, or 17.6%) during the extension phase. On average, patients who needed no injections during this phase had:

• Shorter duration of diabetes (2 years) and DME (9.6 months) at baseline
• Less likelihood of having proliferative diabetic retinopathy at baseline
• Greater likelihood of Diabetic Retinopathy Severity Scale improvement of 2 steps or more
• Fewer rescue focal macular laser treatments during the core RIDE/RISE studies

The need for less frequent injection during the extension phase was associated with less central foveal thickness at RIDE/RISE baseline (P = 0.0002) and at the end of RIDE/RISE (month 36) (P < 0.0001) as well as with less leakage on fluorescein angiography at month 36 (P = 0.014). In addition, glycated hemoglobin level (HbA_1c) at month 36 was found to be inversely proportional to the number of annualized injections needed during the extension phase (P = 0.005).

According to the study investigators, these data indicate that earlier anti-VEGF treatment of center-involving DME causing a loss in visual acuity may reduce the long-term burden of treatment of the disease. Moreover, they noted that earlier treatment appears to result in better ultimate visual outcomes in this patient population as well.