Duration 5min, Q&A 3min
Baseline Characteristics and Results of the RETAIN Study in Patients with Visual Impairment Due to DME Comparing Treat-and-Extend Regimen of Ranibizumab 0.5 mg with/without Laser versus Ranibizumab 0.5 mg Pro-Re-Nata
Several studies with different dosing regimens have established the efficacy and safety profiles of ranibizumab in patients with visual impairment (VI) due to diabetic macular edema (DME). Although monthly injections provided the best possible visual acuity (VA) benefits, considerable heterogeneity was observed with respect to treatment requirements. Pro-re-nata (PRN) dosing regimen addressed the individual patient needs and reduced the treatment burden; however, it still required monthly monitoring and retreatment based on disease activity. The treat-and-extend (TE) approach allows treatment before recurrence of DME with patient-specific monitoring/treatment-free intervals. Here, we present the baseline characteristics and results of patients enrolled in RETAIN that compares the efficacy and safety profiles of ranibizumab-TE regimen with/without laser versus ranibizumab-PRN in patients with DME.
The study enrolled 372 patients with VI due to DME.
Randomized, single-masked, multicenter, 24-month, phase IIIb study. Patients were randomized (1:1:1) to receive ranibizumab-TE+laser (G1; n=121), ranibizumab-TE (G2; n=128), or ranibizumab-PRN (G3; n=123). All patients received ranibizumab on Day1. In phase-A, patients from G1 (laser treatment was also administered on Day1, and then at investigators' discretion according to ETDRS guidelines) and G2 received monthly ranibizumab until VA stability (no change in VA for three consecutive visits), followed by Phase-B allowing 1-month(M) incremental extension of the monitoring/treatment-free interval (maximally up to 3M). Phase-A was resumed upon VA loss due to DME. In G3, patients received monthly ranibizumab until VA stability (Phase-A) followed by monthly monitoring; patients re-entered Phase-A if VA decreased due to DME. Key evaluation parameters included non-inferiority of ranibizumab-TE as monotherapy/adjunctive to laser versus ranibizumab-PRN and, if successful, to test for superiority, assessed by mean average change in best-corrected visual acuity (BCVA) from baseline to M1 through M12 (primary objective); mean change in BCVA and central subfield thickness (CSFT) from baseline to M24; treatment exposure; and safety over 24M.
Results and Conclusion
Demographic characteristics (mean age: 63.0-64.5 years, 60.2%-64.5% males, 94.2%-98.4% Caucasian) and disease characteristics (diabetes type-2: 90.6%-91.9%; mean HbA1c: 7.8%-8.0%; mean time since DME diagnosis: 2.5-2.6 years) were comparable across all treatment groups. Baseline BCVA in patients from G1, G2, and G3 was 61.7, 63.9, and 64.7 letters, respectively. Mean CSFT was numerically greater in patients from G1 (470.5μm) compared with G2 and G3 (444.8μm and 426.2μm). Overall, the baseline characteristics of patients in RETAIN are comparable to those observed in the pivotal studies RESOLVE and RESTORE. Preliminary results suggest that VA outcomes and number of injections administered were similar across all groups.
[ Keyword ]
RETAIN / Ranibizumab / DME / Treat-and-extend
[ Conflict of Interest ]
[ Conflict of Interest (Potential conflict) ]
Consultant: Novartis, Alcon, Allergan, Bayer; Speaker: Novartis, Alcon, Bayer