Ranibizumab 0.5 mg treat-and-extend regimen for diabetic macular oedema: the RETAIN study.
- Prünte C Department of Ophthalmology, Vista Klinik, Binningen, Switzerland Kantonsspital Baselland, Eye Clinic, Liestal, Switzerland University of Basel, Basel, Switzerland.
- Fajnkuchen F Centre d'Imagerie et Laser, Paris, France.
- Mahmood S Royal Eye Hospital, Manchester, UK.
- Ricci F PTV Foundation, University of Rome "Tor Vergata", Rome, Italy.
- Hatz K Department of Ophthalmology, Vista Klinik, Binningen, Switzerland University of Basel, Basel, Switzerland.
- Studnička J Department of Ophthalmology, University Hospital, Hradec Králové, Czech Republic.
- Bezlyak V Novartis Pharma AG, Basel, Switzerland.
- Parikh S Novartis Pharma AG, Basel, Switzerland.
- Stubbings WJ Novartis Pharma AG, Basel, Switzerland.
- Wenzel A Novartis Pharma AG, Basel, Switzerland.
- Figueira J AIBILI, Coimbra, Portugal Coimbra Hospital and University Centre, Coimbra, Portugal Faculty of Medicine, University of Coimbra, Coimbra, Portugal.
- 2015-10-11
Published in:
- The British journal of ophthalmology. - 2016
Clinical Trial
Macula
Treatment Lasers
Treatment Medical
Vision
Angiogenesis Inhibitors
Diabetic Retinopathy
Dose-Response Relationship, Drug
Female
Follow-Up Studies
Humans
Intravitreal Injections
Macula Lutea
Macular Edema
Male
Middle Aged
Ranibizumab
Retrospective Studies
Single-Blind Method
Time Factors
Tomography, Optical Coherence
Treatment Outcome
Vascular Endothelial Growth Factor A
Visual Acuity
English
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.
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.
- Language
-
- English
- Open access status
- hybrid
- Identifiers
-
- DOI 10.1136/bjophthalmol-2015-307249
- PMID 26453639
- Persistent URL
- https://sonar.ch/global/documents/299182
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