Ranibizumab 0.5â
mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study.
Br J Ophthalmol
; 100(6): 787-95, 2016 Jun.
Article
em En
| MEDLINE
| ID: mdl-26453639
ABSTRACT
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 111 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 ≥2â months over 24â 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.Palavras-chave
Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Acuidade Visual
/
Edema Macular
/
Fator A de Crescimento do Endotélio Vascular
/
Retinopatia Diabética
/
Ranibizumab
/
Macula Lutea
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article