Ranibizumab versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial

Kodjikian, Laurent; Souied, Eric H.; Mimoun, G.; Mauget‐Faÿsse, Martine; Behar‐Cohen, Francine; Decullier, Évelyne; Huot, Laure; Aulagner, G.

doi:10.1016/j.ophtha.2013.06.020

Cited by 226 publications

(198 citation statements)

References 23 publications

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“…Table 3 compares findings from this study with clinical trial results. The CATT 6 and IVAN 7,9 studies achieved mean improvement from 0 to 12 months of 6.8 and 5.0 letters, respectively, with seven injections, whereas the Groupe d'Etude Français Avastin versus Lucentis dans la DMLA néovasculaire (GEFAL) 17 and Multicentre Anti-VEGF Trial in Austria (MANTA) 18 studies showed mean improvement of 2.9 and 4.1 letters, respectively, with six injections, which is comparable to the mean improvement of 2.5 letters with six injections in this study. These results suggest that a similar benchmark of +2.5 letters improvement (0-12 months) with six injections represents quality ongoing care that is achievable in a real-world, public hospital setting.…”

Section: Discussionmentioning

confidence: 99%

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The UK Neovascular AMD Database Report 3: inter-centre variation in visual acuity outcomes and establishing real-world measures of care

Liew

Lee

Zarranz‐Ventura

et al. 2016

Eye

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Purpose International variations in visual acuity (VA) outcomes of eyes treated for neovascular age-related macular degeneration (nAMD) are well-documented, but intracountry inter-centre regional variations are not known. These data are important for national quality outcome indicators. We aimed to determine intra-country and intercentre regional variations in outcomes for treatment of nAMD. Patients and methods Prospective multicentre national database study of 13 UK centres that treated patients according to a set protocol (three loading doses, followed by Pro-Re-Nata retreatment). A total of 5811 treatment naive eyes of 5205 patients received a total of 36 206 ranibizumab injections over 12 months. Results Mean starting VA between centres varied from 48.9 to 59.9 ETDRS letters. Mean inter-centre VA change from baseline to 12 months varied from +6.9 letters to − 0.6 letters (mean of +2.5 letters). The proportion of eyes achieving VA of 70 letters or more varied between 21.9 and 48.7% at 12 months. Median number of injections (visits) at each centre varied from 5 to 8 (9 to 12), with an overall median of 6 (11). Age, starting VA, number of injections, and visits, but not gender were significantly associated with variation in these VA outcomes (Po0.01). Significant variation between centres persisted even after adjusting for these factors. Conclusion There are modest differences in VA outcomes between centres in the UK. These differences are influenced, but not completely explained, by factors such as patient age, starting VA, number of injections, and visits. These data provide an indication of the VA outcomes that are achievable in real-world settings.

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Section: Discussionmentioning

confidence: 99%

“…We acknowledge Paul Donachie, Gloucestershire Hospitals NHS Foundation Trust, for providing statistical advice on the manuscript. 16 Warrington and Halton Hospitals NHS Foundation Trust, UK; 17 University of Sydney, Sydney, New South Wales, Australia.…”

Section: Acknowledgementsmentioning

confidence: 99%

The UK Neovascular AMD Database Report 3: inter-centre variation in visual acuity outcomes and establishing real-world measures of care

Liew

Lee

Zarranz‐Ventura

et al. 2016

Eye

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“…Several studies have evaluated the relative efficacies of these bevacizumab and ranibizumab for treatment of AMD and found no difference in visual acuity or complications (Subramanian et al 2010;Biswas et al 2011;Chakravarthy et al 2013;Kodjikian et al 2013;Krebs et al 2013). The CATT study found monthly treatments of bevacizumab not inferior to monthly ranibizumab, although ranibizumab had a greater mean decrease in central retinal thickness and bevacizumab had more serious systemic adverse events (CATT Research Group et al 2011).…”

Section: Rvomentioning

confidence: 99%

Corticosteroids and Anti-Complement Therapy in Retinal Diseases

Narayanan

Kuppermann

2016

Handbook of Experimental Pharmacology

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“…Multiple trials have compared ranibizumab with bevacizumab in multiple treatment regimens for comparative efficacy and safety analysis. The results of all these trials, including the IVAN 3 study, CATT 2 trial, MANTA 4 trial, LUCAS 1 trial, and GEFAL 8 trial, have shown that bevacizumab is noninferior to ranibizumab with a similar safety profile.…”

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confidence: 99%

Retrospective Efficacy and Safety Analysis of Zybev (Biosimilar of Bevacizumab) Use at Tertiary Eye Care Centres in India: Spectra Trial.

Warudkar.¹

2018

IJAR

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Purpose:The purpose of this study was to evaluate the efficacy and safety profile of intravitreal injection of bevacizumabbiosimilar (Zybev) for various retinal neovascular conditions. Methods: Retrospective analysis was carried out on 108 injections which were administered with intravitrealZybev injection at different tertiary eye care centers in India. The injections were administered for various indications such as wet age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO). Results: The mean age of the patients was 62.7 ± 8.40 years. A total of 61.1% injections were administered to men and 39.9% to women. The indications for which the injection was administered were DME (43.6%), AMD (28.7 %), and RVO (27.7%). Mean pretreatment BCVA was 0.94 ± 0.29 logMAR with CMT 355.76 ± 54.9 μm and postinjection BCVA at day 30 was 0.81 ± 0.26 logMAR with CMT reducing to 292.20 ± 40.81 μm, indicating statistical significance (P = 0.001 and P < 0.0001, respectively) for all groups. Among the ocular side effects, none of the patients were reported with severe inflammation, endophthalmitis or rise in intraocular pressure (IOP) >21 mm of Hg during follow up period of one month post injection. No systemic adverse events were noted in study population. Conclusion:This retrospective analysis provides real time evidence regarding the efficacy and safety profile of biosimilar of bevacizumab, Zybev. However, more long term, prospective safety and efficacy studies are still awaited, this short term restropectivedata suggest that Zybev can be effective and safe in the management of ocular conditions including DME, wet AMD and RVO.

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Ranibizumab versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial

Cited by 226 publications

References 23 publications

The UK Neovascular AMD Database Report 3: inter-centre variation in visual acuity outcomes and establishing real-world measures of care

The UK Neovascular AMD Database Report 3: inter-centre variation in visual acuity outcomes and establishing real-world measures of care

Corticosteroids and Anti-Complement Therapy in Retinal Diseases

Retrospective Efficacy and Safety Analysis of Zybev (Biosimilar of Bevacizumab) Use at Tertiary Eye Care Centres in India: Spectra Trial.

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