Two-year outcomes of the APOLLON observational study of intravitreal aflibercept monotherapy in France in patients with diabetic macular edema

APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) over 24 months in routine clinical practice in France. The primary endpoint was mean change from baseline in best-corrected visual...

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Published in	Scientific reports Vol. 12; no. 1; p. 18242
Main Authors	Korobelnik, Jean-François, Daien, Vincent, Faure, Céline, Tadayoni, Ramin, Giocanti-Aurégan, Audrey, Dot, Corinne, Kodjikian, Laurent, Massin, Pascale
Format	Journal Article
Language	English
Published	London Nature Publishing Group UK 29.10.2022 Nature Publishing Group Nature Portfolio
Subjects	692/308 692/699/3161/3175 Acuity Angiogenesis Inhibitors - therapeutic use Clinical medicine Diabetes Diabetes mellitus Diabetes Mellitus - drug therapy Diabetic retinopathy Diabetic Retinopathy - drug therapy Edema Humanities and Social Sciences Humans Intravitreal Injections Life Sciences Macular Edema - drug therapy multidisciplinary NCT NCT02924311 Observational studies Patients Receptors, Vascular Endothelial Growth Factor - therapeutic use Recombinant Fusion Proteins - therapeutic use Retinopathy Santé publique et épidémiologie Science Science (multidisciplinary) Treatment Outcome France
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Abstract	APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) over 24 months in routine clinical practice in France. The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) by 12 months, and safety was monitored throughout the study. Of 402 patients enrolled across 61 participating clinics and hospitals in France, 168 patients were followed for at least 24 months and included in the effectiveness analyses (79 treatment-naïve and 89 previously treated). After 24 months of IVT-AFL treatment, the mean (± standard deviation [SD]) change in BCVA from baseline was + 6.5 (± 10.7) letters in treatment-naïve patients (p < 0.001) and + 1.6 (± 17.0) letters in previously treated patients (p = 0.415) from a baseline of 63.8 (± 13.6) and 60.5 (± 16.5) letters. The mean number of IVT-AFL treatments over 24 months was 11.3 (± 4.9) and 11.9 (± 4.7) for treatment-naïve and previously treated patients. This final analysis of the APOLLON study indicated that following 24 months of IVT-AFL treatment in routine clinical practice in France, treatment-naïve patients with DME achieved significant gains in visual acuity and previously treated patients maintained prior visual acuity gains. Trial registration number: NCT02924311.
AbstractList	APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) over 24 months in routine clinical practice in France. The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) by 12 months, and safety was monitored throughout the study. Of 402 patients enrolled across 61 participating clinics and hospitals in France, 168 patients were followed for at least 24 months and included in the effectiveness analyses (79 treatment-naïve and 89 previously treated). After 24 months of IVT-AFL treatment, the mean (± standard deviation [SD]) change in BCVA from baseline was + 6.5 (± 10.7) letters in treatment-naïve patients (p < 0.001) and + 1.6 (± 17.0) letters in previously treated patients (p = 0.415) from a baseline of 63.8 (± 13.6) and 60.5 (± 16.5) letters. The mean number of IVT-AFL treatments over 24 months was 11.3 (± 4.9) and 11.9 (± 4.7) for treatment-naïve and previously treated patients. This final analysis of the APOLLON study indicated that following 24 months of IVT-AFL treatment in routine clinical practice in France, treatment-naïve patients with DME achieved significant gains in visual acuity and previously treated patients maintained prior visual acuity gains.Trial registration number: NCT02924311. APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) over 24 months in routine clinical practice in France. The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) by 12 months, and safety was monitored throughout the study. Of 402 patients enrolled across 61 participating clinics and hospitals in France, 168 patients were followed for at least 24 months and included in the effectiveness analyses (79 treatment-naïve and 89 previously treated). After 24 months of IVT-AFL treatment, the mean (± standard deviation [SD]) change in BCVA from baseline was + 6.5 (± 10.7) letters in treatment-naïve patients (p < 0.001) and + 1.6 (± 17.0) letters in previously treated patients (p = 0.415) from a baseline of 63.8 (± 13.6) and 60.5 (± 16.5) letters. The mean number of IVT-AFL treatments over 24 months was 11.3 (± 4.9) and 11.9 (± 4.7) for treatment-naïve and previously treated patients. This final analysis of the APOLLON study indicated that following 24 months of IVT-AFL treatment in routine clinical practice in France, treatment-naïve patients with DME achieved significant gains in visual acuity and previously treated patients maintained prior visual acuity gains.Trial registration number: NCT02924311. APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) over 24 months in routine clinical practice in France. The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) by 12 months, and safety was monitored throughout the study. Of 402 patients enrolled across 61 participating clinics and hospitals in France, 168 patients were followed for at least 24 months and included in the effectiveness analyses (79 treatment-naïve and 89 previously treated). After 24 months of IVT-AFL treatment, the mean (± standard deviation [SD]) change in BCVA from baseline was + 6.5 (± 10.7) letters in treatment-naïve patients (p < 0.001) and + 1.6 (± 17.0) letters in previously treated patients (p = 0.415) from a baseline of 63.8 (± 13.6) and 60.5 (± 16.5) letters. The mean number of IVT-AFL treatments over 24 months was 11.3 (± 4.9) and 11.9 (± 4.7) for treatment-naïve and previously treated patients. This final analysis of the APOLLON study indicated that following 24 months of IVT-AFL treatment in routine clinical practice in France, treatment-naïve patients with DME achieved significant gains in visual acuity and previously treated patients maintained prior visual acuity gains. Trial registration number: NCT02924311. Abstract APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) over 24 months in routine clinical practice in France. The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) by 12 months, and safety was monitored throughout the study. Of 402 patients enrolled across 61 participating clinics and hospitals in France, 168 patients were followed for at least 24 months and included in the effectiveness analyses (79 treatment-naïve and 89 previously treated). After 24 months of IVT-AFL treatment, the mean (± standard deviation [SD]) change in BCVA from baseline was + 6.5 (± 10.7) letters in treatment-naïve patients (p < 0.001) and + 1.6 (± 17.0) letters in previously treated patients (p = 0.415) from a baseline of 63.8 (± 13.6) and 60.5 (± 16.5) letters. The mean number of IVT-AFL treatments over 24 months was 11.3 (± 4.9) and 11.9 (± 4.7) for treatment-naïve and previously treated patients. This final analysis of the APOLLON study indicated that following 24 months of IVT-AFL treatment in routine clinical practice in France, treatment-naïve patients with DME achieved significant gains in visual acuity and previously treated patients maintained prior visual acuity gains. Trial registration number: NCT02924311. Abstract APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema (DME) over 24 months in routine clinical practice in France. The primary endpoint was mean change from baseline in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study letters) by 12 months, and safety was monitored throughout the study. Of 402 patients enrolled across 61 participating clinics and hospitals in France, 168 patients were followed for at least 24 months and included in the effectiveness analyses (79 treatment-naïve and 89 previously treated). After 24 months of IVT-AFL treatment, the mean (± standard deviation [SD]) change in BCVA from baseline was + 6.5 (± 10.7) letters in treatment-naïve patients (p < 0.001) and + 1.6 (± 17.0) letters in previously treated patients (p = 0.415) from a baseline of 63.8 (± 13.6) and 60.5 (± 16.5) letters. The mean number of IVT-AFL treatments over 24 months was 11.3 (± 4.9) and 11.9 (± 4.7) for treatment-naïve and previously treated patients. This final analysis of the APOLLON study indicated that following 24 months of IVT-AFL treatment in routine clinical practice in France, treatment-naïve patients with DME achieved significant gains in visual acuity and previously treated patients maintained prior visual acuity gains. Trial registration number: NCT02924311.
ArticleNumber	18242
Author	Giocanti-Aurégan, Audrey Daien, Vincent Korobelnik, Jean-François Faure, Céline Dot, Corinne Tadayoni, Ramin Kodjikian, Laurent Massin, Pascale
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CitedBy_id	crossref_primary_10_1111_aos_15799 crossref_primary_10_1080_08820538_2023_2243308 crossref_primary_10_1007_s40123_023_00829_3
Cites_doi	10.1016/j.ophtha.2016.07.032 10.1007/s00417-019-04592-9 10.1007/s00417-020-04798-2 10.1038/s41598-021-97644-2 10.1056/NEJMoa1414264 10.1038/s41433-021-01624-9 10.1186/2193-1801-2-222 10.1136/bjophthalmol-2020-315933 10.1016/j.ophtha.2015.06.017 10.1136/bmjopen-2013-004015 10.1159/000458539 10.1056/NEJM199412013312203 10.1007/s00417-019-04414-y 10.1016/j.ophtha.2016.02.022 10.1016/j.ophtha.2014.05.006 10.1016/S2214-109X(20)30489-7
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References	CR3 Liew, Michaelides, Bunce (CR1) 2014; 4 Wells (CR11) 2016; 123 CR12 Dong, Peng (CR15) 2013; 2 Angermann (CR17) 2019; 257 Aiello (CR4) 1994; 331 Korobelnik (CR6) 2014; 121 Kim (CR16) 2021; 11 Ehlken (CR7) 2020; 258 Schmidt-Erfurth (CR2) 2017; 237 Brown (CR5) 2015; 122 Ciulla, Pollack, Williams (CR8) 2021; 105 Korobelnik (CR13) 2020; 258 Heier (CR9) 2016; 123 et al (CR14) 2015; 372 Sivaprasad (CR10) 2022; 36 JS Heier (22838_CR9) 2016; 123 et al (22838_CR14) 2015; 372 JF Korobelnik (22838_CR6) 2014; 121 22838_CR12 JA Wells (22838_CR11) 2016; 123 JF Korobelnik (22838_CR13) 2020; 258 G Liew (22838_CR1) 2014; 4 DM Brown (22838_CR5) 2015; 122 TA Ciulla (22838_CR8) 2021; 105 Y Dong (22838_CR15) 2013; 2 U Schmidt-Erfurth (22838_CR2) 2017; 237 LP Aiello (22838_CR4) 1994; 331 S Sivaprasad (22838_CR10) 2022; 36 JS Kim (22838_CR16) 2021; 11 22838_CR3 C Ehlken (22838_CR7) 2020; 258 R Angermann (22838_CR17) 2019; 257
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Ophthalmol. doi: 10.1007/s00417-020-04798-2 contributor: fullname: Ehlken – volume: 11 start-page: 18353 year: 2021 ident: CR16 article-title: Visual/anatomical outcome of diabetic macular edema patients lost to follow-up for more than 1 year publication-title: Sci. Rep. doi: 10.1038/s41598-021-97644-2 contributor: fullname: Kim – volume: 372 start-page: 1193 year: 2015 end-page: 1203 ident: CR14 article-title: Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema publication-title: N. Engl. J. Med. doi: 10.1056/NEJMoa1414264 contributor: fullname: et al – ident: CR3 – volume: 36 start-page: 64 year: 2022 end-page: 71 ident: CR10 article-title: Evaluation of standard of care intravitreal aflibercept treatment of diabetic macular oedema treatment-naive patients in the UK: DRAKO study 12-month outcomes publication-title: Eye (Lond.) doi: 10.1038/s41433-021-01624-9 contributor: fullname: Sivaprasad – volume: 2 start-page: 222 year: 2013 ident: CR15 article-title: Principled missing data methods for researchers publication-title: SpringerPlus. doi: 10.1186/2193-1801-2-222 contributor: fullname: Peng – volume: 105 start-page: 216 year: 2021 end-page: 221 ident: CR8 article-title: Visual acuity outcomes and anti-VEGF therapy intensity in diabetic macular oedema: A real-world analysis of 28 658 patient eyes publication-title: Br. J. 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Rep. doi: 10.1038/s41598-021-97644-2 contributor: fullname: JS Kim – volume: 121 start-page: 2247 year: 2014 ident: 22838_CR6 publication-title: Ophthalmology doi: 10.1016/j.ophtha.2014.05.006 contributor: fullname: JF Korobelnik – ident: 22838_CR3 doi: 10.1016/S2214-109X(20)30489-7 – volume: 122 start-page: 2044 year: 2015 ident: 22838_CR5 publication-title: Ophthalmology doi: 10.1016/j.ophtha.2015.06.017 contributor: fullname: DM Brown – volume: 2 start-page: 222 year: 2013 ident: 22838_CR15 publication-title: SpringerPlus. doi: 10.1186/2193-1801-2-222 contributor: fullname: Y Dong – volume: 123 start-page: 2376 year: 2016 ident: 22838_CR9 publication-title: Ophthalmology doi: 10.1016/j.ophtha.2016.07.032 contributor: fullname: JS Heier – volume: 258 start-page: 521 year: 2020 ident: 22838_CR13 publication-title: Graefes Arch. Clin. Exp. 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Snippet	APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic macular... Abstract APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic... Abstract APOLLON (NCT02924311) was a prospective observational study to evaluate the effectiveness of intravitreal aflibercept (IVT-AFL) treatment of diabetic...
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SubjectTerms	692/308 692/699/3161/3175 Acuity Angiogenesis Inhibitors - therapeutic use Clinical medicine Diabetes Diabetes mellitus Diabetes Mellitus - drug therapy Diabetic retinopathy Diabetic Retinopathy - drug therapy Edema Humanities and Social Sciences Humans Intravitreal Injections Life Sciences Macular Edema - drug therapy multidisciplinary NCT NCT02924311 Observational studies Patients Receptors, Vascular Endothelial Growth Factor - therapeutic use Recombinant Fusion Proteins - therapeutic use Retinopathy Santé publique et épidémiologie Science Science (multidisciplinary) Treatment Outcome
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Title	Two-year outcomes of the APOLLON observational study of intravitreal aflibercept monotherapy in France in patients with diabetic macular edema
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