1. Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept
- Author
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Justus G. Garweg, Jana Stefanickova, Carel Hoyng, Thomas Schmelter, Tobias Niesen, Olaf Sowade, Sobha Sivaprasad, Alfredo Adan, Mikulas Alexik, Fareed Ali, Miguel Amaro, Vilma-Jurate Balciuniene, Francesco M. Bandello, Lluis Arias Barquet, Anna Beck, Katharina Bell, Francesco Boscia, Anniken Bures, Ângela Carneiro, David R. Chow, Andrius Cimbalas, Claudia Dahlke, Varma Deepali, John D. Dickinson, Michael Dollin, Chiara Eandi, Karl-Heinz Emmerich, Nicolas Feltgen, João Pereira Figueira, Oliver Findl, Monika Gajdošová, Richard P. Gale, Ivan John Galic, Justus Garweg, Vanessa Gasser-Steiner, Michel Giunta, John R. Gonder, Andrzej Grzybowski, Jan Hamouz, Lars-Olof Hattenbach, Frank G. Holz, Hasan Jesia, Jozef Kaluzny, Agnes Kerenyi, Peter J. Kertes, Frank Koch, Laurent Kodjikan, David E. Lederer, Ivana Liehneova, Katrin Lorenz, Andrew J. Lotery, Martin McKibbin, Geeta V. Menon, Zofia Michalewska, Edoardo Midena, Massimo Nicolo, Andras Papp, Gabriela Pavlovičová, Enrico Peiretti, Sara Vaz-Pereira, Paolo Perri, Ioannis Petropoulos, Frederic Queguiner, Krystyna Raczynska, Laura Sararols-Ramsay, Marek Rękas, Federico Ricci, Bozena Romanowska-Dixon, Helmut G. Sachs, Saddek Mohand-Said, Dirk Sandner, Ursula Schmidt-Erfurth, Walter Sekundo, Andras Seres, Eric Souied, João Castro de Sousa, Andrzej Stankiewicz, Jana Štefaničková, Katarína Struhárová, Jan Studnicka, Enrique Cervera Taulet, Simon Taylor, Slawomir Teper, Attila Vajas, Carlos Cava Valenciano, Balázs Varsányi, Francesco Viola, Gianni Virgili, Lars Wagenfeld, Gavin Walters, Peter Wiedemann, and Tomasz Zarnowski
- Subjects
medicine.medical_specialty ,Visual acuity ,genetic structures ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Endophthalmitis ,Randomized controlled trial ,Quality of life ,law ,Ophthalmology ,Diabetes mellitus ,Medicine ,Adverse effect ,030304 developmental biology ,Aflibercept ,0303 health sciences ,business.industry ,Diabetic retinopathy ,medicine.disease ,eye diseases ,030221 ophthalmology & optometry ,medicine.symptom ,business ,medicine.drug - Abstract
Purpose To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY). Design AQUA was a multicenter, open-label, single-arm, phase 4 study. Participants Adults 18 years of age or older with type 1 or 2 diabetes mellitus and DME. Methods Patients received intravitreal aflibercept 2 mg every 8 weeks for 52 weeks, after 5 initial doses every 4 weeks. Main Outcome Measures The primary outcome was the change in 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) total score from baseline to week 52. Secondary outcomes included the change in NEI VFQ-25 near and distant activities subscale scores, best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters), and central retinal thickness (CRT) from baseline to week 52. Change in NEI VFQ-25 score at week 52 for better-seeing eyes (BSEs) and worse-seeing eyes (WSEs) also was evaluated. Results A total of 553 patients comprised the full analysis set, and 560 patients comprised the safety analysis set. At baseline, the mean NEI VFQ-25 total score was 70.12, mean BCVA was 61.5 ETDRS letters, and mean CRT was 464.81 μm. A mean of 8.8 injections were administered over 52 weeks. At week 52, the mean improvement from baseline in the NEI VFQ-25 total score was +6.11 (standard deviation [SD], 11.46); the corresponding improvements in near and distant activities were +11.37 (SD, 18.01) and +7.33 (SD, 17.32), respectively. Similarly, improvements in patients whose BSE and WSE were treated were 7.74 (SD, 13.59) and 5.48 (SD, 9.70), respectively. At week 52, mean change in BCVA was +10.0 ETDRS letters (SD, 8.0 ETDRS letters), and mean change in CRT was –175.38 μm (SD, 132.62 μm). Overall, 53.6% of patients reported treatment-emergent adverse events (TEAEs), of whom 26.8% experienced an ocular TEAE in the study eye. The most common serious ocular TEAE was endophthalmitis (0.5% [n = 3]). Five deaths (0.9%) were reported, but were not considered treatment related. Conclusions Intravitreal aflibercept was associated with clinically meaningful improvements in NEI VFQ-25 total score over 52 weeks in patients with DME; these were even more pronounced for near than for distant activities. Adverse events were consistent with the known safety profile of intravitreal aflibercept.
- Published
- 2019
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