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

British journal of ophthalmology, 2016-06, Vol.100 (6), p.787-795 [Peer Reviewed Journal]

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 ;Copyright: 2016 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 ;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/ 2016 ;ISSN: 0007-1161 ;EISSN: 1468-2079 ;DOI: 10.1136/bjophthalmol-2015-307249 ;PMID: 26453639 ;CODEN: BJOPAL

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Title:
Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study
Author: Prünte, Christian ; Fajnkuchen, Franck ; Mahmood, Sajjad ; Ricci, Federico ; Hatz, Katja ; Studnička, Jan ; Bezlyak, Vladimir ; Parikh, Soumil ; Stubbings, William John ; Wenzel, Andreas ; Figueira, João
Subjects: Angiogenesis Inhibitors - administration & dosage ; Clinical Science ; Diabetic Retinopathy - complications ; Diabetic Retinopathy - diagnosis ; Dose-Response Relationship, Drug ; Female ; Follow-Up Studies ; Humans ; Intravitreal Injections ; Macula Lutea - diagnostic imaging ; Macular Edema - diagnosis ; Macular Edema - drug therapy ; Macular Edema - etiology ; Male ; Middle Aged ; Ranibizumab - administration & dosage ; Retrospective Studies ; Single-Blind Method ; Time Factors ; Tomography, Optical Coherence ; Treatment Outcome ; Vascular Endothelial Growth Factor A - antagonists & inhibitors ; Visual Acuity
Is Part Of: British journal of ophthalmology, 2016-06, Vol.100 (6), p.787-795
Description: AimsTo 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).MethodsA 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.ResultsBoth 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.ConclusionsT&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 numberNCT01171976.
Publisher: England: BMJ Publishing Group LTD
Language: English
Identifier: ISSN: 0007-1161
EISSN: 1468-2079
DOI: 10.1136/bjophthalmol-2015-307249
PMID: 26453639
CODEN: BJOPAL
Source: BMJ Open Access Journals
MEDLINE
ProQuest Central

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

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