-
Something wrong with this record ?
Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study
C. Prünte, F. Fajnkuchen, S. Mahmood, F. Ricci, K. Hatz, J. Studnička, V. Bezlyak, S. Parikh, WJ. Stubbings, A. Wenzel, J. Figueira, . ,
Language English Country England, Great Britain
Document type Journal Article, Multicenter Study, Randomized Controlled Trial
NLK
ProQuest Central
from 1922-01-01 to 6 months ago
Health & Medicine (ProQuest)
from 1922-01-01 to 6 months ago
- MeSH
- Time Factors MeSH
- Diabetic Retinopathy complications diagnosis MeSH
- Angiogenesis Inhibitors administration & dosage MeSH
- Intravitreal Injections MeSH
- Single-Blind Method MeSH
- Middle Aged MeSH
- Humans MeSH
- Macula Lutea diagnostic imaging MeSH
- Macular Edema diagnosis drug therapy etiology MeSH
- Follow-Up Studies MeSH
- Tomography, Optical Coherence MeSH
- Ranibizumab administration & dosage MeSH
- Retrospective Studies MeSH
- Vascular Endothelial Growth Factor A antagonists & inhibitors MeSH
- Treatment Outcome MeSH
- Dose-Response Relationship, Drug MeSH
- Visual Acuity * MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
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.
Centre d'Imagerie et Laser Paris France
Department of Ophthalmology University Hospital Hradec Králové Czech Republic
Department of Ophthalmology Vista Klinik Binningen Switzerland University of Basel Basel Switzerland
Novartis Pharma AG Basel Switzerland
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc17024223
- 003
- CZ-PrNML
- 005
- 20170831103606.0
- 007
- ta
- 008
- 170720s2016 enk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1136/bjophthalmol-2015-307249 $2 doi
- 035 __
- $a (PubMed)26453639
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a enk
- 100 1_
- $a Prünte, Christian $u Department of Ophthalmology, Vista Klinik, Binningen, Switzerland Kantonsspital Baselland, Eye Clinic, Liestal, Switzerland University of Basel, Basel, Switzerland.
- 245 10
- $a Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study / $c C. Prünte, F. Fajnkuchen, S. Mahmood, F. Ricci, K. Hatz, J. Studnička, V. Bezlyak, S. Parikh, WJ. Stubbings, A. Wenzel, J. Figueira, . ,
- 520 9_
- $a 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.
- 650 _2
- $a inhibitory angiogeneze $x aplikace a dávkování $7 D020533
- 650 _2
- $a diabetická retinopatie $x komplikace $x diagnóza $7 D003930
- 650 _2
- $a vztah mezi dávkou a účinkem léčiva $7 D004305
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a následné studie $7 D005500
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a injekce intravitreální $7 D058449
- 650 _2
- $a macula lutea $x diagnostické zobrazování $7 D008266
- 650 _2
- $a makulární edém $x diagnóza $x farmakoterapie $x etiologie $7 D008269
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a ranibizumab $x aplikace a dávkování $7 D000069579
- 650 _2
- $a retrospektivní studie $7 D012189
- 650 _2
- $a jednoduchá slepá metoda $7 D016037
- 650 _2
- $a časové faktory $7 D013997
- 650 _2
- $a optická koherentní tomografie $7 D041623
- 650 _2
- $a výsledek terapie $7 D016896
- 650 _2
- $a vaskulární endoteliální růstový faktor A $x antagonisté a inhibitory $7 D042461
- 650 12
- $a zraková ostrost $7 D014792
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 700 1_
- $a Fajnkuchen, Franck $u Centre d'Imagerie et Laser, Paris, France.
- 700 1_
- $a Mahmood, Sajjad $u Royal Eye Hospital, Manchester, UK.
- 700 1_
- $a Ricci, Federico $u PTV Foundation, University of Rome "Tor Vergata", Rome, Italy.
- 700 1_
- $a Hatz, Katja $u Department of Ophthalmology, Vista Klinik, Binningen, Switzerland University of Basel, Basel, Switzerland.
- 700 1_
- $a Studnička, Jan $u Department of Ophthalmology, University Hospital, Hradec Králové, Czech Republic.
- 700 1_
- $a Bezlyak, Vladimir $u Novartis Pharma AG, Basel, Switzerland.
- 700 1_
- $a Parikh, Soumil $u Novartis Pharma AG, Basel, Switzerland.
- 700 1_
- $a Stubbings, William John $u Novartis Pharma AG, Basel, Switzerland.
- 700 1_
- $a Wenzel, Andreas $u Novartis Pharma AG, Basel, Switzerland.
- 700 1_
- $a Figueira, João $u AIBILI, Coimbra, Portugal Coimbra Hospital and University Centre, Coimbra, Portugal Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
- 700 1_
- $a ,
- 773 0_
- $w MED00000875 $t The British journal of ophthalmology $x 1468-2079 $g Roč. 100, č. 6 (2016), s. 787-95
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/26453639 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20170720 $b ABA008
- 991 __
- $a 20170831104156 $b ABA008
- 999 __
- $a ok $b bmc $g 1239904 $s 985136
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2016 $b 100 $c 6 $d 787-95 $e 20151009 $i 1468-2079 $m British journal of ophthalmology $n Br J Ophthalmol $x MED00000875
- LZP __
- $a Pubmed-20170720
