Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study

Garweg J. G.;Stefanickova J.;Hoyng C.;Schmelter T.;Niesen T.;Sowade O.;Sivaprasad S.;Adan A.;Alexik M.;Ali F.;Amaro M.;Balciuniene V. -J.;Bandello F. M.;Arias Barquet L.;Beck A.;Bell K.;Boscia F.;Bures A.;Carneiro A.;Chow D. R.;Cimbalas A.;Dahlke C.;Deepali V.;Dickinson J. D.;Dollin M.;Eandi C.;Emmerich K. -H.;Feltgen N.;Pereira Figueira J.;Findl O.;Gajdosova M.;Gale R. P.;John Galic I.;Garweg J.;Gasser-Steiner V.;Giunta M.;Gonder J. R.;Grzybowski A.;Hamouz J.;Hattenbach L. -O.;Holz F. G.;Jesia H.;Kaluzny J.;Kerenyi A.;Kertes P. J.;Koch F.;Kodjikan L.;Lederer D. E.;Liehneova I.;Lorenz K.;Lotery A. J.;McKibbin M.;Menon G. V.;Michalewska Z.;Midena E.;Nicolo M.;Papp A.;Pavlovicova G.;Peiretti E.;Vaz-Pereira S.;Perri P.;Petropoulos I.;Queguiner F.;Raczynska K.;Sararols-Ramsay L.;Rekas M.;Ricci F.;Romanowska-Dixon B.;Sachs H. G.;Mohand-Said S.;Sandner D.;Schmidt-Erfurth U.;Sekundo W.;Seres A.;Souied E.;Castro de Sousa J.;Stankiewicz A.;Stefanickova J.;Struharova K.;Studnicka J.;Cervera Taulet E.;Taylor S.;Teper S.;Vajas A.;Cava Valenciano C.;Varsanyi B.;Viola F.;Virgili G.;Wagenfeld L.;Walters G.;Wiedemann P.;Zarnowski T.

2019-01-01

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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.