Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept

Hoyng, Carel C B; Schmelter, Thomas; Niesen, Tobias; Sowade, Olaf; Adán, Alfredo; Alexík, M; Ali, Fareed; Amaro, Miguel Hage; Balciuniene, Vilma-Jurate; Bandello, Francesco; Barquet, L. Arias; Beck, Anna; Bell, Katharina; Boscia, Francesco; Bures, Anniken; Carneiro, Ângela; Chow, David R.; Cimbalas, Andrius; Dahlke, Claudia; Varma, Deepali; Dickinson, John D.; Dollin, Michael; Eandi, Chiara M; Emmerich, Karl-Heinz; Feltgen, Nicolas; Figueira, João; Findl, Oliver; Gajdošová, Monika; Gale, Richard; Galić, Ivan; Garweg, Justus G.; Gasser-Steiner, Vanessa; Giunta, Michel; Gonder, John R.; Grzybowski, Andrzej; Hamouz, Jan; Hattenbach, Lars‐Olof; Holz, Frank G.; Hasan, Jesia; Kałuzny, J; Kerényi, Ágnes; Kertes, Peter J.; Koch, Frank; Kodjikan, Laurent; Lederer, David E.; Liehneová, I; Lorenz, Katrin; Lotery, Andrew; McKibbin, Martin; Menon, Geeta; Michalewska, Zofia; Midena, Edoardo; Nicolò, Massimo; Papp, András; Pavlovičová, Gabriela; Peiretti, Enrico; Vaz-Pereira, Sara; Perri, Paolo; Petropoulos, Ioannis N.; Queguiner, Frederic; Raczyńska, Krystyna; Sararols-Ramsay, Laura; Rękas, Marek; Ricci, Federico; Romanowska–Dixon, Bożena; Sachs, Helmut; Mohand‐Saïd, Saddek; Sandner, Dirk; Schmidt‐Erfurth, Ursula; Sekundo, Walter; Seres, András; Sivaprasad, Sobha; Souied, Eric H.; Sousa, João C.; Stankiewicz, Andrzej; Stefanickova, Jana; Struharova, K; Studnička, Jan; Taulet, Enrique Cervera; Taylor, Simon; Teper, Sławomir; Vajas, Attila; Valenciano, Carlos Cava; Varsányi, Balázs; Viola, Francesco; Virgili, Gianni; Wagenfeld, Lars; Walters, Gavin; Wiedemann, Peter; Żarnowski, Tomasz

doi:10.1016/j.oret.2019.03.012

Cited by 21 publications

(19 citation statements)

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“…2 b). A patient retention rate of 70–80% over 5 years in both groups adds to the 1-year findings of two prospective studies on high patient satisfaction [ 29 , 30 ].…”

Section: Discussionmentioning

confidence: 65%

Long-term outcomes of intravitreal therapy for symptomatic diabetic macular oedema in a real-world setting in Switzerland

Zirpel

Pfister

Gerhardt

et al. 2021

Graefes Arch Clin Exp Ophthalmol

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Objective To assess the long-term visual outcomes in eyes with symptomatic diabetic macular oedema (DME) under intravitreal treatment (IVT) in a clinical routine setting. Methods Patients with newly diagnosed DME were included in this retrospective study if they had received at least three IVTs and a follow-up period ≥ 2 years. Due to altered treatment patterns since the approval of ranibizumab for DME in 2012, patients were subdivided according to their first IVT before 2013 (group 1) or thereafter (group 2). The primary outcome measure was the evolution of best-corrected visual acuity (BCVA) over time. Results Of 217 eyes (191 patients) with DME, 151 eyes (117 patients) fulfilled the inclusion criteria (63 eyes in the first period, 88 in the second period). Mean follow-up time was 7.9 ± 3.1 (group 1) and 4.1 ± 1.4 years (group 2; p < 0.001). Visual gains were similar in the first year (group 1: + 5.3 ± 15.5, group 2: + 7.3 ± 12.2 Early Treatment Diabetic Retinopathy Study (ETDRS) letters; p = 0.44), but not thereafter (after 2 years in group 1: + 4.4 ± 15.0, group 2: + 8.3 ± 13.0 ETDRS letters; p = 0.038). During the first year, group 1 patients received less clinical examinations (group 1: 6.6 ± 3.3, group 2: 7.5 ± 2.1; p = 0.007) and less injections (group 1: 3.6 ± 2.7, group 2: 6.1 ± 2.7; p < 0.001). Conclusion A greater visual gain, in response to more intensive treatment during the first year, was maintained for at least 5 years in group 2 subjects. Our data confirm that in a real-world setting, early intensive treatment results in satisfying long-term visual outcomes.

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“…2 b). A patient retention rate of 70–80% over 5 years in both groups adds to the 1-year findings of two prospective studies on high patient satisfaction [ 29 , 30 ].…”

Section: Discussionmentioning

confidence: 65%

Long-term outcomes of intravitreal therapy for symptomatic diabetic macular oedema in a real-world setting in Switzerland

Zirpel

Pfister

Gerhardt

et al. 2021

Graefes Arch Clin Exp Ophthalmol

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“…Two patients in each of the fixed and T&E groups and one patient in the PRN group had no post-baseline assessments available and were excluded from the FAS. More than 95% of patients enrolled after completing the AQUA study, in which > 90% of patients received all nine IVT-AFL injections in Year 1 per the protocol (mean number of injections: 8.8 [95% CI 8.7–8.9]) [ 9 ]. The Week 100 visit was completed by 88.4% ( n = 137), 89.6% ( n = 138), and 88.3% ( n = 136) of patients in the fixed, T&E, and PRN groups, respectively (Fig.…”

Section: Resultsmentioning

confidence: 99%

“…Most patients in the VIOLET study had participated in the AQUA study and, in that study, achieved a mean gain in BCVA of + 10 letters after 1 year of treatment [ 9 ]; therefore, no substantial improvements were expected during the VIOLET study. Improvements in BCVA and CRT achieved in the year prior to enrollment in VIOLET were maintained over the second and third years of treatment with either a fixed, T&E, or PRN dosing regimen.…”

Section: Discussionmentioning

confidence: 99%

“…Patients were enrolled from either the AQUA study (NCT02581995; an open-label, single-arm study designed to evaluate vision-related quality of life in patients who received five initial monthly injections of IVT-AFL 2 mg, followed by treatment q8w until Week 52) or from outside the AQUA study, if they fulfilled the eligibility criteria. Details of the AQUA study are published elsewhere [ 9 ].…”

Section: Methodsmentioning

confidence: 99%

“…Patients who had received prior treatment with IVT-AFL for ≥ 1 year under the guidance of the European label – five initial monthly IVT-AFL 2 mg injections, followed by an IVT-AFL injection q8w (for patients enrolled from the AQUA study [ 9 ]) or treatment within allowed time windows for interval deviations (patients enrolled outside the AQUA study) – were eligible for inclusion. Patients were aged ≥ 18 years, with type 1 or type 2 diabetes mellitus and DME with central macular involvement (defined as the area of the center subfield on spectral domain optical coherence tomography [OCT]), BCVA 73–24 ETDRS letters (20/40–20/320 Snellen equivalent) in the study eye at pre-study treatment initiation.…”

Section: Methodsmentioning

confidence: 99%

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Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial

et al. 2022

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Introduction The purpose was to compare two flexible regimens of intravitreal aflibercept (IVT-AFL) with fixed dosing every 8 weeks, beyond the first year of treatment, in patients with diabetic macular edema (DME). VIOLET was a 100-week, randomized, Phase IIIb, non-inferiority study in patients with center-involving DME previously treated with IVT-AFL for ≥ 1 year according to the European label. Methods Patients received an initial dose of IVT-AFL at study baseline and were randomly assigned (1:1:1) to treat-and-extend (T&E), pro re nata (PRN), or fixed regimens. The primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline (randomization) to Week 52. Results Full analysis set comprised 458 patients (baseline mean BCVA: 72.5, 71.0, and 72.7 letters in the T&E, PRN, and fixed-dose groups, respectively). Patients received a mean (min–max) of 10.0 (2–14; T&E), 11.5 (1–25; PRN), and 12.3 (3–13; fixed) injections over 100 weeks, with 13.3 (4–23), 25.0 (3–29), and 16.1 (5–25) clinic visits, respectively. At Week 52, mean (± standard deviation) BCVA changes from baseline were + 0.5 ± 6.7 (T&E), + 1.7 ± 6.8 (PRN), and + 0.4 ± 6.7 (fixed-dosing) letters (least squares mean difference [95% confidence interval]: T&E 0.01 [− 1.46, 1.47] and PRN 0.95 (− 0.52, 2.42) letters versus fixed dosing; p < 0.0001 for both non-inferiority tests [4-letter margin]). The IVT-AFL safety profile was consistent with previous studies. Conclusion The treatment burden associated with intravitreal injections for DME is lowest with T&E regimens, but there are a range of flexible IVT-AFL dosing regimens, allowing physicians to adopt an individualized treatment plan. Trial Registration ClinicalTrials.gov identifier: NCT02818998. Supplementary Information The online version contains supplementary material available at 10.1007/s12325-022-02119-z.

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Quality of Life in Diabetic Macular Edema

Anupriya¹,

Saxena²

2022

Diabetic Macular Edema

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Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept

Cited by 21 publications

References 21 publications

Long-term outcomes of intravitreal therapy for symptomatic diabetic macular oedema in a real-world setting in Switzerland

Long-term outcomes of intravitreal therapy for symptomatic diabetic macular oedema in a real-world setting in Switzerland

Dosing Regimens of Intravitreal Aflibercept for Diabetic Macular Edema Beyond the First Year: VIOLET, a Prospective Randomized Trial

Quality of Life in Diabetic Macular Edema

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