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Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study

AIMS: To demonstrate non-inferiority of ranibizumab treat-and-extend (T&E) with/without laser to ranibizumab pro re nata (PRN) for best-corrected visual acuity (BCVA) in patients with diabetic macular oedema (DMO). METHODS: A 24-month single-masked study with patients randomised 1:1:1 to T&E...

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Autores principales: Prünte, Christian, Fajnkuchen, Franck, Mahmood, Sajjad, Ricci, Federico, Hatz, Katja, Studnička, Jan, Bezlyak, Vladimir, Parikh, Soumil, Stubbings, William John, Wenzel, Andreas, Figueira, João
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4893084/
https://www.ncbi.nlm.nih.gov/pubmed/26453639
http://dx.doi.org/10.1136/bjophthalmol-2015-307249
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author Prünte, Christian
Fajnkuchen, Franck
Mahmood, Sajjad
Ricci, Federico
Hatz, Katja
Studnička, Jan
Bezlyak, Vladimir
Parikh, Soumil
Stubbings, William John
Wenzel, Andreas
Figueira, João
author_facet Prünte, Christian
Fajnkuchen, Franck
Mahmood, Sajjad
Ricci, Federico
Hatz, Katja
Studnička, Jan
Bezlyak, Vladimir
Parikh, Soumil
Stubbings, William John
Wenzel, Andreas
Figueira, João
author_sort Prünte, Christian
collection PubMed
description AIMS: To demonstrate non-inferiority of ranibizumab treat-and-extend (T&E) with/without laser to ranibizumab pro re nata (PRN) for best-corrected visual acuity (BCVA) in patients with diabetic macular oedema (DMO). METHODS: A 24-month single-masked study with patients randomised 1:1:1 to T&E+laser (n=121), T&E (n=128) or PRN (control; n=123). All patients received monthly injections until BCVA stabilisation. The investigator decided on re-treatment in the PRN and treatment-interval adaptations in the T&E groups based on loss of BCVA stability due to DMO activity. Likewise, laser treatment was at investigator's discretion. Collectively, these features reflect a real-life scenario. Endpoints included mean average change in BCVA from baseline to months 1–12 (primary), mean BCVA change from baseline to months 12 and 24, treatment exposure and safety profile. RESULTS: Both T&E regimens were non-inferior to PRN based on mean average BCVA change from baseline to months 1–12 (T&E+laser: +5.9 and T&E: +6.1 vs PRN: +6.2 letters; both p<0.0001). Mean BCVA change at month 24 was similar across groups (+8.3, +6.5 and +8.1 letters, respectively). The mean number of injections was 12.4 and 12.8 in the T&E+laser and T&E groups and 10.7 in the PRN group. The T&E regimens showed 46% reduction in the number of clinic visits. Over 70% of patients maintained their BCVA, with treatment intervals of ≥2 months over 24 months. Safety profile was consistent with that described in the product information. CONCLUSIONS: T&E is a feasible treatment option for patients with DMO, with a potential to reduce treatment burden. Slightly more injections were required versus PRN, likely due to the specifics of the T&E regimen applied here. TRIAL REGISTRATION NUMBER: NCT01171976.
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spelling pubmed-48930842016-06-09 Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study Prünte, Christian Fajnkuchen, Franck Mahmood, Sajjad Ricci, Federico Hatz, Katja Studnička, Jan Bezlyak, Vladimir Parikh, Soumil Stubbings, William John Wenzel, Andreas Figueira, João Br J Ophthalmol Clinical Science AIMS: To demonstrate non-inferiority of ranibizumab treat-and-extend (T&E) with/without laser to ranibizumab pro re nata (PRN) for best-corrected visual acuity (BCVA) in patients with diabetic macular oedema (DMO). METHODS: A 24-month single-masked study with patients randomised 1:1:1 to T&E+laser (n=121), T&E (n=128) or PRN (control; n=123). All patients received monthly injections until BCVA stabilisation. The investigator decided on re-treatment in the PRN and treatment-interval adaptations in the T&E groups based on loss of BCVA stability due to DMO activity. Likewise, laser treatment was at investigator's discretion. Collectively, these features reflect a real-life scenario. Endpoints included mean average change in BCVA from baseline to months 1–12 (primary), mean BCVA change from baseline to months 12 and 24, treatment exposure and safety profile. RESULTS: Both T&E regimens were non-inferior to PRN based on mean average BCVA change from baseline to months 1–12 (T&E+laser: +5.9 and T&E: +6.1 vs PRN: +6.2 letters; both p<0.0001). Mean BCVA change at month 24 was similar across groups (+8.3, +6.5 and +8.1 letters, respectively). The mean number of injections was 12.4 and 12.8 in the T&E+laser and T&E groups and 10.7 in the PRN group. The T&E regimens showed 46% reduction in the number of clinic visits. Over 70% of patients maintained their BCVA, with treatment intervals of ≥2 months over 24 months. Safety profile was consistent with that described in the product information. CONCLUSIONS: T&E is a feasible treatment option for patients with DMO, with a potential to reduce treatment burden. Slightly more injections were required versus PRN, likely due to the specifics of the T&E regimen applied here. TRIAL REGISTRATION NUMBER: NCT01171976. BMJ Publishing Group 2016-06 2015-10-09 /pmc/articles/PMC4893084/ /pubmed/26453639 http://dx.doi.org/10.1136/bjophthalmol-2015-307249 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
spellingShingle Clinical Science
Prünte, Christian
Fajnkuchen, Franck
Mahmood, Sajjad
Ricci, Federico
Hatz, Katja
Studnička, Jan
Bezlyak, Vladimir
Parikh, Soumil
Stubbings, William John
Wenzel, Andreas
Figueira, João
Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study
title Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study
title_full Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study
title_fullStr Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study
title_full_unstemmed Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study
title_short Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study
title_sort ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the retain study
topic Clinical Science
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4893084/
https://www.ncbi.nlm.nih.gov/pubmed/26453639
http://dx.doi.org/10.1136/bjophthalmol-2015-307249
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