TY - JOUR
T1 - Intravitreal Aflibercept for Diabetic Macular Edema
T2 - 148-Week Results from the VISTA and VIVID Studies
AU - Heier, Jeffrey S.
AU - Korobelnik, Jean François
AU - Brown, David M.
AU - Schmidt-Erfurth, Ursula
AU - Do, Diana V.
AU - Midena, Edoardo
AU - Boyer, David 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 - Vitti, Robert
AU - Berliner, Alyson J.
AU - Zeitz, Oliver
AU - Metzig, Carola
AU - Holz, Frank G.
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, Regeneron Pharmaceuticals, Inc. Additional editorial assistance was provided by Leigh Prevost, PAREXEL, and funded by Bayer HealthCare.
Publisher Copyright:
© 2016 American Academy of Ophthalmology
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Purpose To compare efficacy and safety of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME) over 3 years. Design Two similarly designed phase 3 trials: VISTADME and VIVIDDME. Participants Patients (eyes; n = 872) with central-involved DME. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. From week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8. From week 100, laser control patients who had not received IAI rescue treatment received IAI as needed per retreatment criteria. Main Outcome Measures The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at week 52. We report the 148-week results. Results Mean BCVA gain from baseline to week 148 with IAI 2q4, IAI 2q8, and laser control was 10.4, 10.5, and 1.4 letters (P < 0.0001) in VISTA and 10.3, 11.7, and 1.6 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 148 was 42.9%, 35.8%, and 13.6% (P < 0.0001) in VISTA and 41.2%, 42.2%, and 18.9% (P < 0.0001) in VIVID, respectively. Greater proportions of eyes treated with IAI 2q4 and IAI 2q8 versus those treated with laser control had an improvement of ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score in both VISTA (29.9% and 34.4% vs. 20.1% [P = 0.0350, IAI 2q4; P = 0.0052, IAI 2q8]) and VIVID (44.3% and 47.8% vs. 17.4% [P < 0.0001 for both]). In an integrated safety analysis, the most frequent ocular serious adverse event was cataract (3.1%, 2.1%, 0.3% for 2q4, 2q8, and control). Conclusions Visual improvements observed with both IAI regimens (over laser control) at weeks 52 and 100 were maintained at week 148, with similar overall efficacy in the IAI 2q4 and IAI 2q8 groups. Treatment with IAI also had positive effects on the DRSS score. Over 148 weeks, the incidence of adverse events was consistent with the known safety profile of IAI.
AB - Purpose To compare efficacy and safety of intravitreal aflibercept injection (IAI) with macular laser photocoagulation for diabetic macular edema (DME) over 3 years. Design Two similarly designed phase 3 trials: VISTADME and VIVIDDME. Participants Patients (eyes; n = 872) with central-involved DME. Methods Eyes received IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 8 weeks after 5 monthly doses (2q8), or laser control. From week 24, if rescue treatment criteria were met, IAI patients received active laser, and laser control patients received IAI 2q8. From week 100, laser control patients who had not received IAI rescue treatment received IAI as needed per retreatment criteria. Main Outcome Measures The primary end point was the change from baseline in best-corrected visual acuity (BCVA) at week 52. We report the 148-week results. Results Mean BCVA gain from baseline to week 148 with IAI 2q4, IAI 2q8, and laser control was 10.4, 10.5, and 1.4 letters (P < 0.0001) in VISTA and 10.3, 11.7, and 1.6 letters (P < 0.0001) in VIVID, respectively. The proportion of eyes that gained ≥15 letters from baseline at week 148 was 42.9%, 35.8%, and 13.6% (P < 0.0001) in VISTA and 41.2%, 42.2%, and 18.9% (P < 0.0001) in VIVID, respectively. Greater proportions of eyes treated with IAI 2q4 and IAI 2q8 versus those treated with laser control had an improvement of ≥2 steps in the Diabetic Retinopathy Severity Scale (DRSS) score in both VISTA (29.9% and 34.4% vs. 20.1% [P = 0.0350, IAI 2q4; P = 0.0052, IAI 2q8]) and VIVID (44.3% and 47.8% vs. 17.4% [P < 0.0001 for both]). In an integrated safety analysis, the most frequent ocular serious adverse event was cataract (3.1%, 2.1%, 0.3% for 2q4, 2q8, and control). Conclusions Visual improvements observed with both IAI regimens (over laser control) at weeks 52 and 100 were maintained at week 148, with similar overall efficacy in the IAI 2q4 and IAI 2q8 groups. Treatment with IAI also had positive effects on the DRSS score. Over 148 weeks, the incidence of adverse events was consistent with the known safety profile of IAI.
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U2 - 10.1016/j.ophtha.2016.07.032
DO - 10.1016/j.ophtha.2016.07.032
M3 - Article
C2 - 27651226
AN - SCOPUS:84994879789
SN - 0161-6420
VL - 123
SP - 2376
EP - 2385
JO - Ophthalmology
JF - Ophthalmology
IS - 11
ER -