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Christian Pruente, RETAIN Study Group; Efficacy and safety of ranibizumab in two treat-and-extend versus pro-re-nata regimes in patients with visual impairment due to diabetic macular edema: 24-month results of RETAIN study. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1700.
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The RETAIN study explored the non-inferiority/superiority of a treat-and-extend (TE) regimen of ranibizumab (RBZ), with/without laser, to a pro-re-nata (PRN) regimen in patients (pts) with visual impairment due to diabetic macular edema (DME). PRN requires monthly monitoring, while TE aims at maintaining maximized visual acuity (VA) with individualized treatment (Tx) intervals. Here we present the 24-month (M) efficacy and safety of ranibizumab 0.5 mg (RBZ) in two TE regimens vs PRN
RETAIN was a phase IIIb single-masked multicenter study with pts randomized 1:1:1 to TE-RBZ+laser (G1; n=121), TE-RBZ (G2; n=128), or PRN-RBZ (G3; n=123). G1 pts received laser on Day1, then laser PRN as per early treatment diabetic retinopathy study (ETDRS) guidelines. In Phase A, all pts received monthly RBZ until VA stability. In Phase B, the Tx-free interval could be incrementally extended by 1M (up to 3M) in VA-stable pts in G1 and G2. In G3, pts had PRN-RBZ in Phase B. All pts re-entered Phase A on VA decrease due to DME. Key objective: non-inferiority (margin of 4 letters)/superiority testing of G1 and G2 vs G3 based on mean average change in best-corrected visual acuity (BCVA) from baseline (BSL) to M1 through M12 (primary endpoint), mean BCVA change from BSL-M24; Tx exposure and safety profile over 24M
Baseline pts had mild to moderate vision loss (mean BCVA of 63.4 ETDRS letters). About 332 (89.2%) pts completed the study. Both G1 and G2 were non-inferior to G3 based on mean average BCVA change from BSL to M1 through M12 (+5.9 and +6.1 vs +6.2 letters; both P<0.0001; primary objective based on non-inferiority met; superiority not shown). Mean change in BCVA from BSL at M24 was similar across G1, G2 and G3 (+8.3, +6.5, and +8.1 letters). Median injection number over 24M was 12 for G1 and G2 and 10 for G3. There was approximately a 40% reduction in pt Tx visits scheduled with TE; approximately 70% of TE pts had a monitoring interval of ≥2 months. There were no new safety findings over 24M
The RETAIN study confirms the well-established efficacy and safety profiles of RBZ and demonstrates that RBZ TE regimens were non-inferior to PRN in the RETAIN DME pts with mild to moderate vision loss. The TE regimens led to a potential reduction in number of pts visit based on individual pts response
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