Patients in the open-label extension phase of RIDE/RISE who needed Lucentis less frequently tended to have less advanced diabetic macular edema (DME) at extension baseline and to respond better to initial treatment, according to post hoc analysis. These results suggest that earlier treatment of center-involving DME with loss of visual acuity may decrease its long-term treatment burden.
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:
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 (HbA1c) 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.