Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F16%3A10318459" target="_blank" >RIV/00179906:_____/16:10318459 - isvavai.cz</a>
Result on the web
<a href="http://bjo.bmj.com/content/early/2015/10/16/bjophthalmol-2015-307249" target="_blank" >http://bjo.bmj.com/content/early/2015/10/16/bjophthalmol-2015-307249</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1136/bjophthalmol-2015-307249" target="_blank" >10.1136/bjophthalmol-2015-307249</a>
Alternative languages
Result language
angličtina
Original language name
Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study
Original language 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 GREATER-THAN OR EQUAL TO2 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.
Czech name
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Czech description
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Classification
Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FF - ENT (ie. ear, nose, throat), ophthalmology, dentistry
OECD FORD branch
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Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2016
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
British Journal of Ophthalmology
ISSN
0007-1161
e-ISSN
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Volume of the periodical
100
Issue of the periodical within the volume
6
Country of publishing house
GB - UNITED KINGDOM
Number of pages
9
Pages from-to
787-795
UT code for WoS article
000376994700014
EID of the result in the Scopus database
2-s2.0-84971411336