TY - JOUR
T1 - Intravitreal aflibercept for diabetic macular edema
T2 - 100-week results from the VISTA and VIVID studies
AU - Brown, David M.
AU - Schmidt-Erfurth, Ursula
AU - Do, Diana V.
AU - Holz, Frank G.
AU - Boyer, David S.
AU - Midena, Edoardo
AU - Heier, Jeffrey S.
AU - Terasaki, Hiroko
AU - Kaiser, Peter K.
AU - Marcus, Dennis M.
AU - Nguyen, Quan D.
AU - Jaffe, Glenn J.
AU - Slakter, Jason S.
AU - Simader, Christian
AU - Soo, Yuhwen
AU - Schmelter, Thomas
AU - Yancopoulos, George D.
AU - Stahl, Neil
AU - Vitti, Robert
AU - Berliner, Alyson J.
AU - Zeitz, Oliver
AU - Metzig, Carola
AU - Korobelnik, Jean François
N1 - Funding Information:
Assistance with the study design and conduct and data analysis was provided by Karen Chu, MS, and Xiaoping Zhu, PhD, Regeneron Pharmaceuticals, Inc (VISTA), and Jana Sachsinger, PhD, and Christiane Norenberg, MS, Bayer HealthCare (VIVID and integrated safety analysis of VISTA and VIVID). Editorial and administrative assistance to the authors was provided by Hadi Moini, PhD, and S. Balachandra Dass, PhD, Regeneron Pharmaceuticals, Inc. Additional editorial assistance was provided by Corey Eagan, MPH, PAREXEL, and funded by Bayer HealthCare.
Publisher Copyright:
© 2015 American Academy of Ophthalmology.
PY - 2015/10/1
Y1 - 2015/10/1
N2 - Purpose To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME). Design Two similarly designed, randomized, phase 3 trials, VISTADME and VIVIDDME. Participants Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. Main Outcome Measures The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained 15 letters, and proportion of eyes with a 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. Results Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters (P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained 15 letters from baseline at week 100 was 38.3%, 33.1%, and 13.0% (P < 0.0001) in VISTA and 38.2%, 31.1%, and 12.1% (P ≤ 0.0001) in VIVID. The proportion of eyes that lost 15 letters at week 100 was 3.2%, 0.7%, and 9.7% (P ≤ 0.0220) in VISTA and 2.2%, 1.5%, and 12.9% (P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a 2 step improvement in the DRSS score in both VISTA (37.0% and 37.1% vs. 15.6%; P < 0.0001) and VIVID (29.3% and 32.6% vs. 8.2%; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and control). Conclusions In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI.
AB - Purpose To compare efficacy and safety of 2 dosing regimens of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME). Design Two similarly designed, randomized, phase 3 trials, VISTADME and VIVIDDME. Participants Patients (eyes; n=872) with type 1 or 2 diabetes mellitus who had DME with central involvement. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. Main Outcome Measures The primary end point was mean change from baseline in best-corrected visual acuity (BCVA) at week 52. This report presents the 100-week results including mean change from baseline in BCVA, proportion of eyes that gained 15 letters, and proportion of eyes with a 2-step improvement in the Diabetic Retinopathy Severity Scale (DRSS) score. Results Mean BCVA gain from baseline to week 100 with IAI 2q4, IAI 2q8, and laser control was 11.5, 11.1, and 0.9 letters (P < 0.0001) in VISTA and 11.4, 9.4, and 0.7 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained 15 letters from baseline at week 100 was 38.3%, 33.1%, and 13.0% (P < 0.0001) in VISTA and 38.2%, 31.1%, and 12.1% (P ≤ 0.0001) in VIVID. The proportion of eyes that lost 15 letters at week 100 was 3.2%, 0.7%, and 9.7% (P ≤ 0.0220) in VISTA and 2.2%, 1.5%, and 12.9% (P ≤ 0.0008) in VIVID. Significantly more eyes in the IAI 2q4 and 2q8 groups versus those in the laser control group had a 2 step improvement in the DRSS score in both VISTA (37.0% and 37.1% vs. 15.6%; P < 0.0001) and VIVID (29.3% and 32.6% vs. 8.2%; P ≤ 0.0004). In an integrated safety analysis, the most frequent serious ocular adverse event was cataract (2.4%, 1.0%, and 0.3% for 2q4, 2q8, and control). Conclusions In both VISTA and VIVID, the 52-week visual and anatomic superiority of IAI over laser control was sustained through week 100, with similar efficacy in the 2q4 and 2q8 groups. Safety in these studies was consistent with the known safety profile of IAI.
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U2 - 10.1016/j.ophtha.2015.06.017
DO - 10.1016/j.ophtha.2015.06.017
M3 - Article
C2 - 26198808
AN - SCOPUS:84943453717
SN - 0161-6420
VL - 122
SP - 2044
EP - 2052
JO - Ophthalmology
JF - Ophthalmology
IS - 10
ER -