TY - JOUR
T1 - Three-year outcomes of individualized ranibizumab treatment in patients with diabetic macular edema: the RESTORE extension study
AU - Schmidt-Erfurth, Ursula
AU - Lang, Gabriele E.
AU - Holz, Frank G.
AU - Schlingemann, Reinier O.
AU - Lanzetta, Paolo
AU - Massin, Pascale
AU - Gerstner, Ortrud
AU - Bouazza, Abdelkader Si
AU - Shen, Haige
AU - Osborne, Aaron
AU - Mitchell, Paul
AU - AUTHOR GROUP
AU - Papp, Andras
AU - Seres, Andras
AU - Berta, Andras
AU - Pesztenlehrer, Norbert
AU - Weber, Michel
AU - Creuzot- Garcher, Catherine
AU - Emmerich, Karl-Heinz
AU - Engelmann, Katrin
AU - Hansen, Lutz
AU - Kellner, Ulrich
AU - Kirchhof, Bernd
AU - Mohr, Andreas
AU - Spital, Georg
AU - Wiedemann, Peter
AU - Schrage, Norbert
AU - Menchini, Ugo
AU - Balestrazzi, Emilio
AU - Noci, Nicola Delle
AU - Ciriano, J. P. Martinez
AU - Kleverling, Bert Jeroen
AU - van Calster, Joachim
AU - Devriendt, Marlene
AU - Kurz-Levin, Malaika
AU - Jürgens, Inga
AU - Schneider, Ulrike
AU - Garweg, Justus
AU - Tappeiner, Christoph
AU - Gerding, Heinrich
AU - Kloos, Patrik
AU - Eldem, Bora
AU - Sobaci, Gungor
AU - Kapran, Ziya
AU - Ergin, Mehmet
AU - Hasanreisoglu, Berati
AU - Arumi, Josep Garcia
AU - Ulla, Francisco Gomez
AU - Imaz, Ramon Torres
AU - Cervera, Enrique
AU - Civera, Alfredo Adan
PY - 2014
Y1 - 2014
N2 - To evaluate long-term efficacy and safety profiles during 3 years of individualized ranibizumab treatment in patients with visual impairment due to diabetic macular edema (DME). Phase IIIb, multicenter, 12-month, randomized core study and 24-month open-label extension study. Of the 303 patients who completed the randomized RESTORE 12-month core study, 240 entered the extension study. In the extension study, patients were eligible to receive individualized ranibizumab treatment as of month 12 guided by best-corrected visual acuity (BCVA) and disease progression criteria at the investigators' discretion. Concomitant laser treatment was allowed according to the Early Treatment Diabetic Retinopathy Study guidelines. Based on the treatments received in the core study, the extension study groups were referred to as prior ranibizumab, prior ranibizumab + laser, and laser. Change in BCVA and incidence of ocular and nonocular adverse events (AEs) over 3 years. Overall, 208 patients (86.7%) completed the extension study. In patients treated with ranibizumab during the core study, consecutive individualized ranibizumab treatment during the extension study led to an overall maintenance of BCVA and central retinal subfield thickness (CRST) observed at month 12 over the 2-year extension study (+8.0 letters, -142.1 μm [prior ranibizumab] and +6.7 letters, -145.9 μm [prior ranibizumab + laser] from baseline at month 36) with a median of 6.0 injections (mean, 6.8 injections; prior ranibizumab) and 4.0 (mean, 6.0 injections; prior ranibizumab + laser). In the prior laser group, a progressive BCVA improvement (+6.0 letters) and CRST reduction (-142.7 μm) at month 36 were observed after allowing ranibizumab during the extension study, with a median of 4.0 injections (mean, 6.5 injections) from months 12 to 35. Patients in all 3 treatment groups received a mean of <3 injections in the final year. No cases of endophthalmitis, retinal tear, or retinal detachment were reported. The most frequently reported ocular and nonocular adverse effects over 3 years were cataract (16.3%) and nasopharyngitis (23.3%). Eight deaths were reported during the extension study, but none were suspected to be related to the study drug/procedure. Ranibizumab was effective in improving and maintaining BCVA and CRST outcomes with a progressively declining number of injections over 3 years of individualized dosing. Ranibizumab was generally well tolerated with no new safety concerns over 3 years
AB - To evaluate long-term efficacy and safety profiles during 3 years of individualized ranibizumab treatment in patients with visual impairment due to diabetic macular edema (DME). Phase IIIb, multicenter, 12-month, randomized core study and 24-month open-label extension study. Of the 303 patients who completed the randomized RESTORE 12-month core study, 240 entered the extension study. In the extension study, patients were eligible to receive individualized ranibizumab treatment as of month 12 guided by best-corrected visual acuity (BCVA) and disease progression criteria at the investigators' discretion. Concomitant laser treatment was allowed according to the Early Treatment Diabetic Retinopathy Study guidelines. Based on the treatments received in the core study, the extension study groups were referred to as prior ranibizumab, prior ranibizumab + laser, and laser. Change in BCVA and incidence of ocular and nonocular adverse events (AEs) over 3 years. Overall, 208 patients (86.7%) completed the extension study. In patients treated with ranibizumab during the core study, consecutive individualized ranibizumab treatment during the extension study led to an overall maintenance of BCVA and central retinal subfield thickness (CRST) observed at month 12 over the 2-year extension study (+8.0 letters, -142.1 μm [prior ranibizumab] and +6.7 letters, -145.9 μm [prior ranibizumab + laser] from baseline at month 36) with a median of 6.0 injections (mean, 6.8 injections; prior ranibizumab) and 4.0 (mean, 6.0 injections; prior ranibizumab + laser). In the prior laser group, a progressive BCVA improvement (+6.0 letters) and CRST reduction (-142.7 μm) at month 36 were observed after allowing ranibizumab during the extension study, with a median of 4.0 injections (mean, 6.5 injections) from months 12 to 35. Patients in all 3 treatment groups received a mean of <3 injections in the final year. No cases of endophthalmitis, retinal tear, or retinal detachment were reported. The most frequently reported ocular and nonocular adverse effects over 3 years were cataract (16.3%) and nasopharyngitis (23.3%). Eight deaths were reported during the extension study, but none were suspected to be related to the study drug/procedure. Ranibizumab was effective in improving and maintaining BCVA and CRST outcomes with a progressively declining number of injections over 3 years of individualized dosing. Ranibizumab was generally well tolerated with no new safety concerns over 3 years
U2 - https://doi.org/10.1016/j.ophtha.2013.11.041
DO - https://doi.org/10.1016/j.ophtha.2013.11.041
M3 - Article
C2 - 24491642
SN - 0161-6420
VL - 121
SP - 1045
EP - 1053
JO - Ophthalmology
JF - Ophthalmology
IS - 5
ER -