Session Title: Vascular Diseases and Diabetic Retinopathy II
Session Date/Time: Friday 18/09/2015 | 16:30-18:00
Paper Time: 17:42
First Author: : F.Bottoni ITALY
Co Author(s): : C. DungerBaldauf P. Margaron G. Staurenghi
PURPOSE:The aim of the study was to investigate the long-term functional outcomes in clinical trials of patients with diabetic macular edema (DME) who experienced an initial best-corrected visual acuity (BCVA) loss within or immediately following the first months of ranibizumab 0.5 mg, and simulate a hypothetical switch from ranibizumab to another anti-vascular endothelial growth factor (anti-VEGF).
Post-hoc analyses in patients with DME from the RESTORE, REVEAL, RETAIN and RESPOND trials.
We conducted the first analysis in patients from the RETAIN (n=372) and RESTORE extension (n=166) trials who were treated with ranibizumab 0.5 mg pro re nata (PRN) or treat and extend (T&E) regimen with or without adjunctive laser and lost ≥4 letters from baseline to Month 1 and/or Month 2. The second analysis included patients from the RESTORE, REVEAL, RETAIN, and RESPOND trials (n=445, pooled data set) who were treated with ranibizumab 0.5 mg PRN monotherapy and who lost ≥4 letters from baseline to Months 4, 5, and 6.
In the RESTORE extension trial, 13.3% (11/83) and 10.8% (9/83) patients from the ranibizumab monotherapy and ranibizumab with or without laser arms, respectively, lost ≥4 letters from baseline to Month 1 and/or Month 2. Subsequently, from the first visit with BCVA loss to Months 12, 24, and 34, the mean BCVA gain for ranibizumab monotherapy patients was 8.8, 11.4, and 13.7 letters, respectively, and 7.3, 11.1, and 10.1 letters for the ranibizumab with or without laser arms. In the RETAIN trial, 13.7% (16/117), 12% (15 of 125), and 9.4% (11/117) patients lost ≥4 letters from baseline to Month 1 and/or Month 2 in the T&E with or without laser, T&E monotherapy, and PRN monotherapy arms, respectively. From the first visit with BCVA loss, the three arms gained a mean of 9.1, 7.2, and 9.9 letters to Month 12, and 11.0, 12.4, and 12.4 letters to Month 23, respectively. In the pooled analysis, 2% (9) patients treated with ranibizumab PRN lost ≥4 letters from baseline to Months 4, 5, and 6; these patients regained a mean of 11.2 letters from Month 6 to Month 12.
These post-hoc analyses showed that a low number of patients treated with ranibizumab PRN or T&E experienced vision loss within 2 months after treatment initiation, or within 3 months after completion of the 3 initial consecutive monthly injections. On average, these patients gained 2 lines at Month 12 and maintained the gains over the long-term period. Uninterrupted ranibizumab 0.5 mg treatment provided benefit with respect to BCVA outcomes in these delayed responders. Switching to a new anti-VEGF treatment can be challenging, as these patients would need to gain an excess of 10–12 letters over 12–24 months to benefit with the alternate treatment.