Original articleIntravitreal Aflibercept for Diabetic Macular Edema
Section snippets
Methods
The VISTA and VIVID studies were 2 phase 3, randomized, double-masked, active-controlled, 148-week trials. The VISTA study (registered at www.clinicaltrials.gov; NCT01363440) was conducted across 54 sites in the United States and the VIVID study (registered at www.clinicaltrials.gov; NCT01331681) was conducted at 73 sites across Europe, Japan, and Australia (Appendix 1 provides a list of study investigators; available at www.aaojournal.org). Each clinical site's respective institutional review
Patient Disposition, Baseline Characteristics, and Treatment Experience
The VISTA study randomized 466 patients and VIVID, 406 patients, each with 1 study eye (Appendix 6; available at www.aaojournal.org). Overall, demographics and baseline characteristics of patients were similar across all treatment groups in both studies (Table 1). However, VISTA included a greater proportion of Black or African-American patients and VIVID had a greater proportion of Asian patients. In addition, more eyes in VISTA had prior anti-VEGF therapy for DME compared with VIVID (42.9% vs
Discussion
The VIVID and VISTA studies provide the first head-to-head comparisons of anti-VEGF blockade alone versus laser therapy alone. The results demonstrate that IAI given either every 4 or every 8 weeks (after 5 initial monthly doses) is superior to laser and results in both significant visual acuity gains and prevention of severe visual acuity loss. The primary efficacy endpoint (change from baseline in BCVA at 52 weeks) was superior in both 2q4 and 2q8 groups compared with the laser group in both
Acknowledgments
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). Editorial and administrative assistance to the authors was provided by Hadi Moini, PhD, and S. Balachandra Dass, PhD, Regeneron Pharmaceuticals, Inc.
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Supplemental material is available at www.aaojournal.org.
Financial Disclosure(s): The authors have made the following disclosures:
Jean-François Korobelnik: Advisory Board – Allergan, Alcon, Novartis; Consultant – Carl Zeiss Meditec, Roche, Thea; Fees (review activities) – Bayer HealthCare.
Diana V. Do: Research Funding – Genentech, Regeneron Pharmaceutical, Inc.
Ursula Schmidt-Erfurth – Consultant – Alcon, Bayer HealthCare, Boehringer, Novartis; Research Funding – Allergan, Alcon, Bayer HealthCare, Novartis; Travel Support – Bayer HealthCare.
David S. Boyer: Advisory Board Member – Alcon, Allergan, Neurotech; Consultant – Alcon, Allergo, Allergan, Bausch & Lomb, Bayer, KalVista, Neurotech, Novartis, Roche, ThromboGenics, GSK; Received Research funding – Genentech, Regeneron Pharmaceuticals, Inc.; Lecture Fee – Allergan.
Frank G. Holz: Consultant – Acucela, Alcon, Allergan, Bayer HealthCare, Boehringer-Ingelheim, Genentech, Heidelberg Engineering, Merz, Novartis, Pfizer; Research Funding –Alcon, Allergan, Bayer HealthCare, Carl Zeiss Meditec, GSK, Heidelberg Engineering, Novartis, Optos; Travel Support – Bayer HealthCare; Lecture Fees – Alcon, Bayer HealthCare, Heidelberg Engineering, Novartis, Pfizer.
Jeffrey S. Heier: Consultant – Acucela, Aerpio, Alcon, Allegro, Allergan, Bayer, Forsight Vision, Genentech, Genzyme, Kala Pharmaceutical, Liquidia, Merz, Neurotech, Ohr Pharmaceutical, Oraya, Regeneron Pharmaceuticals, Inc., Sanofi, Stealth Peptides, Thrombogenics, Xcovery; Research Funding – Acucela, Aerpio, Alcon, Alimera, Genentech, Genzyme, Kato Pharmaceutical, Lpath, Novartis, Ohr, Ophthotech, QLT, Regeneron Pharmaceuticals, Inc.
Edoardo Midena: Research Funding – Bayer HealthCare.
Peter K. Kaiser: Consultant to Bayer HealthCare, Chengdu Kanghong, Genentech, Novartis, Regeneron Pharmaceuticals, Inc.
Hiroko Terasaki: Research Funding – Alcon, Novartis, Pfizer, Santen, Senju, Wacamoto; Lecture Fees – Alcon, Bayer HealthCare, Novartis, Pfizer, Santen, Senju, Wacamoto.
Dennis M. Marcus: Consultant – Genentech, Thrombogenics, Regeneron Pharmaceuticals, Inc.; Research Funding – Regeneron Pharmaceuticals, Inc., Genentech, Thrombogenics, Alcon, Allergan, Ophthotech, GSK, Pfizer, Acucela, LPath, Quark.
Quan D. Nguyen: Research Funding – AbbVie, Genentech, Optos, Regeneron Pharmaceuticals, Inc., Santen, Inc.
Glenn J. Jaffe: Consultant – Heidelberg Engineering, Neurotech; Travel Support – Regeneron Pharmaceuticals, Inc.
Jason S. Slakter: Research Funding – Acucela, Alimera, Bayer HealthCare, Fovea, Genentech, Genzyme, GSK, Kanghong Biotech, LPath, Ohr Pharma, Oraya, Regeneron Pharmaceuticals, Inc., Sanofi, XcoveryVision; Equity Owner – SKS Ocular.
Christian Simader: Payments for masked data evaluation (institutional support, Vienna Reading Center) – Bayer HealthCare, Böhringer Ingelheim, Novartis.
Yuhwen Soo: Employee – Regeneron.
George D. Yancopoulos: Employee – Regeneron; Several patents issued and pending.
Neil Stahl: Employee – Regeneron; Several patents issued and pending.
Robert Vitti: Employee – Regeneron.
Alyson J. Berliner: Employee – Regeneron.
Thomas Schmelter: Employee – Bayer HealthCare.
Oliver Zeitz: Employee – Bayer HealthCare.
Carola Metzig: Employee – Bayer HealthCare.
David M. Brown: Consultant – Allergan, Bayer HealthCare, Genentech, Genzyme, Heidelberg Engineering, Notal Vision, Novartis, QLT, Regeneron, Thrombogenics; Research Funding – Abbott, Acucela, Alimera, Allergan, Ampio, Genentech, Genzyme, GSK, Novartis, Opthotech, Pfizer, pSivida, QLT, Quark, Regeneron Pharmaceuticals, Inc., Santen, Thrombogenics, Xoma; Travel Support – Regeneron Pharmaceuticals, Inc.
The VISTA and VIVID studies were funded by Regeneron Pharmaceuticals, Inc., Tarrytown, NY and Bayer HealthCare, Berlin, Germany. The sponsors participated in the design and conduct of the study, analysis of the data, and preparation of the manuscript.
The investigators from the VISTA and VIVID studies are listed in Appendix 1 (available at www.aaojournal.org).