Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study

Pascale Massin; Francesco Bandello; Justus G Garweg; Lutz L Hansen; Simon P Harding; Michael Larsen; Paul Mitchell; Dianne Sharp; U E K Wolf-Schnurrbusch; Margarita Gekkieva; Andreas Weichselberger; Sebastian Wolf; Lutz L Hansen

doi:http://dx.doi.org/10.2337/dc10-0493

Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study

Pascale Massin, Francesco Bandello, Justus G Garweg, Lutz L Hansen, Simon P Harding, Michael Larsen, Paul Mitchell, Dianne Sharp, U E K Wolf-Schnurrbusch, Margarita Gekkieva, Andreas Weichselberger, Sebastian Wolf, Lutz L Hansen

528 Citationer (Scopus)

Abstract

OBJECTIVE - The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety and efficacy of ranibizumab in DME involving the foveal center. RESEARCH DESIGN AND METHODS - This was a 12-month, multicenter, sham-controlled, double-masked study with eyes (age >18 years, type 1 or 2 diabetes, central retinal thickness [CRT] ≥300 μm, and best corrected visual acuity [BCVA] of 73-39 ETDRS letters [Early Treatment Diabetic Retinopathy Study]) randomly assigned to intravitreal ranibizumab (0.3 or 0.5 mg; n = 51 each) or sham (n = 49). The treatment schedule comprised three monthly injections, after which treatment could be stopped/reinitiated with an opportunity for rescue laser photocoagulation (protocol-defined criteria). After month 1, dose-doubling was permitted (protocol-defined criteria, injection volume increased from 0.05 to 0.1 ml and remained at 0.1 ml thereafter). Efficacy (BCVA and CRT) and safety were compared between pooled ranibizumab and sham arms using the full analysis set (n = 151, patients receiving ≥1 injection). RESULTS - At month 12, mean ± SD BCVA improved from baseline by 10.3 ± 9.1 letters with ranibizumab and declined by 1.4 ± 14.2 letters with sham (P < 0.0001). Mean CRT reductionwas 194.2 ± 135.1 μm with ranibizumab and 48.4 ± 153.4 μm with sham (P < 0.0001). Gain of ≥10 letters BCVA from baseline occurred in 60.8% of ranibizumab and 18.4% of sham eyes (P < 0.0001). Safety data were consistent with previous studies of intravitreal ranibizumab. CONCLUSIONS - Ranibizumab is effective in improving BCVA and is well tolerated in DME. Future clinical trials are required to confirm its long-term efficacy and safety.

Originalsprog	Engelsk
Tidsskrift	Diabetes Care
Vol/bind	33
Udgave nummer	11
Sider (fra-til)	2399-405
Antal sider	7
ISSN	0149-5992
DOI	https://doi.org/10.2337/dc10-0493
Status	Udgivet - 1 nov. 2010

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http://dx.doi.org/10.2337/dc10-0493

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Massin, P., Bandello, F., Garweg, J. G., Hansen, L. L., Harding, S. P., Larsen, M., Mitchell, P., Sharp, D., Wolf-Schnurrbusch, U. E. K., Gekkieva, M., Weichselberger, A., Wolf, S., & Hansen, L. L. (2010). Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study. Diabetes Care, 33(11), 2399-405. https://doi.org/10.2337/dc10-0493

Massin, P, Bandello, F, Garweg, JG, Hansen, LL, Harding, SP, Larsen, M, Mitchell, P, Sharp, D, Wolf-Schnurrbusch, UEK, Gekkieva, M, Weichselberger, A, Wolf, S & Hansen, LL 2010, 'Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study', Diabetes Care, bind 33, nr. 11, s. 2399-405. https://doi.org/10.2337/dc10-0493

@article{8223ed77d0e842dab7dfcc1166cea09a,

title = "Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study",

abstract = "OBJECTIVE - The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety and efficacy of ranibizumab in DME involving the foveal center. RESEARCH DESIGN AND METHODS - This was a 12-month, multicenter, sham-controlled, double-masked study with eyes (age >18 years, type 1 or 2 diabetes, central retinal thickness [CRT] ≥300 μm, and best corrected visual acuity [BCVA] of 73-39 ETDRS letters [Early Treatment Diabetic Retinopathy Study]) randomly assigned to intravitreal ranibizumab (0.3 or 0.5 mg; n = 51 each) or sham (n = 49). The treatment schedule comprised three monthly injections, after which treatment could be stopped/reinitiated with an opportunity for rescue laser photocoagulation (protocol-defined criteria). After month 1, dose-doubling was permitted (protocol-defined criteria, injection volume increased from 0.05 to 0.1 ml and remained at 0.1 ml thereafter). Efficacy (BCVA and CRT) and safety were compared between pooled ranibizumab and sham arms using the full analysis set (n = 151, patients receiving ≥1 injection). RESULTS - At month 12, mean ± SD BCVA improved from baseline by 10.3 ± 9.1 letters with ranibizumab and declined by 1.4 ± 14.2 letters with sham (P < 0.0001). Mean CRT reductionwas 194.2 ± 135.1 μm with ranibizumab and 48.4 ± 153.4 μm with sham (P < 0.0001). Gain of ≥10 letters BCVA from baseline occurred in 60.8% of ranibizumab and 18.4% of sham eyes (P < 0.0001). Safety data were consistent with previous studies of intravitreal ranibizumab. CONCLUSIONS - Ranibizumab is effective in improving BCVA and is well tolerated in DME. Future clinical trials are required to confirm its long-term efficacy and safety.",

author = "Pascale Massin and Francesco Bandello and Garweg, {Justus G} and Hansen, {Lutz L} and Harding, {Simon P} and Michael Larsen and Paul Mitchell and Dianne Sharp and Wolf-Schnurrbusch, {U E K} and Margarita Gekkieva and Andreas Weichselberger and Sebastian Wolf and Hansen, {Lutz L}",

year = "2010",

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doi = "http://dx.doi.org/10.2337/dc10-0493",

language = "English",

volume = "33",

pages = "2399--405",

journal = "Diabetes Care",

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publisher = "American Diabetes Association",

number = "11",

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TY - JOUR

T1 - Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study

AU - Massin, Pascale

AU - Bandello, Francesco

AU - Garweg, Justus G

AU - Hansen, Lutz L

AU - Harding, Simon P

AU - Larsen, Michael

AU - Mitchell, Paul

AU - Sharp, Dianne

AU - Wolf-Schnurrbusch, U E K

AU - Gekkieva, Margarita

AU - Weichselberger, Andreas

AU - Wolf, Sebastian

AU - Hansen, Lutz L

PY - 2010/11/1

Y1 - 2010/11/1

N2 - OBJECTIVE - The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety and efficacy of ranibizumab in DME involving the foveal center. RESEARCH DESIGN AND METHODS - This was a 12-month, multicenter, sham-controlled, double-masked study with eyes (age >18 years, type 1 or 2 diabetes, central retinal thickness [CRT] ≥300 μm, and best corrected visual acuity [BCVA] of 73-39 ETDRS letters [Early Treatment Diabetic Retinopathy Study]) randomly assigned to intravitreal ranibizumab (0.3 or 0.5 mg; n = 51 each) or sham (n = 49). The treatment schedule comprised three monthly injections, after which treatment could be stopped/reinitiated with an opportunity for rescue laser photocoagulation (protocol-defined criteria). After month 1, dose-doubling was permitted (protocol-defined criteria, injection volume increased from 0.05 to 0.1 ml and remained at 0.1 ml thereafter). Efficacy (BCVA and CRT) and safety were compared between pooled ranibizumab and sham arms using the full analysis set (n = 151, patients receiving ≥1 injection). RESULTS - At month 12, mean ± SD BCVA improved from baseline by 10.3 ± 9.1 letters with ranibizumab and declined by 1.4 ± 14.2 letters with sham (P < 0.0001). Mean CRT reductionwas 194.2 ± 135.1 μm with ranibizumab and 48.4 ± 153.4 μm with sham (P < 0.0001). Gain of ≥10 letters BCVA from baseline occurred in 60.8% of ranibizumab and 18.4% of sham eyes (P < 0.0001). Safety data were consistent with previous studies of intravitreal ranibizumab. CONCLUSIONS - Ranibizumab is effective in improving BCVA and is well tolerated in DME. Future clinical trials are required to confirm its long-term efficacy and safety.

AB - OBJECTIVE - The expression of vascular endothelial growth factor (VEGF) is elevated in diabetic macular edema (DME). Ranibizumab binds to and inhibits multiple VEGF variants. We investigated the safety and efficacy of ranibizumab in DME involving the foveal center. RESEARCH DESIGN AND METHODS - This was a 12-month, multicenter, sham-controlled, double-masked study with eyes (age >18 years, type 1 or 2 diabetes, central retinal thickness [CRT] ≥300 μm, and best corrected visual acuity [BCVA] of 73-39 ETDRS letters [Early Treatment Diabetic Retinopathy Study]) randomly assigned to intravitreal ranibizumab (0.3 or 0.5 mg; n = 51 each) or sham (n = 49). The treatment schedule comprised three monthly injections, after which treatment could be stopped/reinitiated with an opportunity for rescue laser photocoagulation (protocol-defined criteria). After month 1, dose-doubling was permitted (protocol-defined criteria, injection volume increased from 0.05 to 0.1 ml and remained at 0.1 ml thereafter). Efficacy (BCVA and CRT) and safety were compared between pooled ranibizumab and sham arms using the full analysis set (n = 151, patients receiving ≥1 injection). RESULTS - At month 12, mean ± SD BCVA improved from baseline by 10.3 ± 9.1 letters with ranibizumab and declined by 1.4 ± 14.2 letters with sham (P < 0.0001). Mean CRT reductionwas 194.2 ± 135.1 μm with ranibizumab and 48.4 ± 153.4 μm with sham (P < 0.0001). Gain of ≥10 letters BCVA from baseline occurred in 60.8% of ranibizumab and 18.4% of sham eyes (P < 0.0001). Safety data were consistent with previous studies of intravitreal ranibizumab. CONCLUSIONS - Ranibizumab is effective in improving BCVA and is well tolerated in DME. Future clinical trials are required to confirm its long-term efficacy and safety.

U2 - http://dx.doi.org/10.2337/dc10-0493

DO - http://dx.doi.org/10.2337/dc10-0493

M3 - Journal article

SN - 0149-5992

VL - 33

SP - 2399

EP - 2405

JO - Diabetes Care

JF - Diabetes Care

IS - 11

ER -

Safety and efficacy of ranibizumab in diabetic macular edema (RESOLVE Study): a 12-month, randomized, controlled, double-masked, multicenter phase II study

Abstract

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