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Ranibizumab versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial.
Ophthalmology 2013; 120(11):2300-9O

Abstract

OBJECTIVE

To evaluate the relative efficacy and safety profile of bevacizumab versus ranibizumab intravitreal injections for the treatment of neovascular age-related macular degeneration (AMD).

DESIGN

Multicenter, prospective, noninferiority, double-masked, randomized clinical trial performed in 38 French ophthalmology centers. The noninferiority limit was 5 letters.

PARTICIPANTS

Patients aged ≥50 years were eligible if they presented with subfoveal neovascular AMD, with best-corrected visual acuity (BVCA) in the study eye of between 20/32 and 20/320 measured on the Early Treatment of Diabetic Retinopathy Study chart and a lesion area of less than 12 optic disc areas (DA).

METHODS

Patients were randomly assigned to intravitreal administration of bevacizumab (1.25 mg) or ranibizumab (0.50 mg). Hospital pharmacies were responsible for preparing, blinding, and dispensing treatments. Patients were followed for 1 year, with a loading dose of 3 monthly intravitreal injections, followed by an as-needed regimen (1 injection in case of active disease) for the remaining 9 months with monthly follow-up.

MAIN OUTCOME MEASURES

Mean change in visual acuity at 1 year.

RESULTS

Between June 2009 and November 2011, 501 patients were randomized. In the per protocol analysis, bevacizumab was noninferior to ranibizumab (bevacizumab minus ranibizumab +1.89 letters; 95% confidence interval [CI], -1.16 to +4.93, P < 0.0001). The intention-to-treat analysis was concordant. The mean number of injections was 6.8 in the bevacizumab group and 6.5 in the ranibizumab group (P = 0.39). Both drugs reduced the central subfield macular thickness, with a mean decrease of 95 μm for bevacizumab and 107 μm for ranibizumab (P = 0.27). There were no significant differences in the presence of subretinal or intraretinal fluid at final evaluation, dye leakage on angiogram, or change in choroidal neovascular area. The proportion of patients with serious adverse events was 12.6% in the bevacizumab group and 12.1% in the ranibizumab group (P = 0.88). The proportion of patients with serious systemic or ocular adverse events was similar in both groups.

CONCLUSIONS

Bevacizumab was noninferior to ranibizumab for visual acuity at 1 year with similar safety profiles. Ranibizumab tended to have a better anatomic outcome. The results are similar to those of previous head-to-head studies.

Authors+Show Affiliations

Hospices Civils de Lyon, Groupement Hospitalier Nord, Hôpital de la Croix-Rousse, Service d'ophtalmologie, Lyon, France; Université de Lyon, Lyon, France; CNRS UMR 5510 Mateis, Villeurbanne, France. Electronic address: laurent.kodjikian@chu-lyon.fr.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23916488

Citation

Kodjikian, Laurent, et al. "Ranibizumab Versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results From the GEFAL Noninferiority Randomized Trial." Ophthalmology, vol. 120, no. 11, 2013, pp. 2300-9.
Kodjikian L, Souied EH, Mimoun G, et al. Ranibizumab versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial. Ophthalmology. 2013;120(11):2300-9.
Kodjikian, L., Souied, E. H., Mimoun, G., Mauget-Faÿsse, M., Behar-Cohen, F., Decullier, E., ... Aulagner, G. (2013). Ranibizumab versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial. Ophthalmology, 120(11), pp. 2300-9. doi:10.1016/j.ophtha.2013.06.020.
Kodjikian L, et al. Ranibizumab Versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results From the GEFAL Noninferiority Randomized Trial. Ophthalmology. 2013;120(11):2300-9. PubMed PMID: 23916488.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ranibizumab versus Bevacizumab for Neovascular Age-related Macular Degeneration: Results from the GEFAL Noninferiority Randomized Trial. AU - Kodjikian,Laurent, AU - Souied,Eric H, AU - Mimoun,Gérard, AU - Mauget-Faÿsse,Martine, AU - Behar-Cohen,Francine, AU - Decullier,Evelyne, AU - Huot,Laure, AU - Aulagner,Gilles, AU - ,, Y1 - 2013/08/02/ PY - 2013/04/16/received PY - 2013/05/31/revised PY - 2013/06/06/accepted PY - 2013/8/7/entrez PY - 2013/8/7/pubmed PY - 2014/1/11/medline SP - 2300 EP - 9 JF - Ophthalmology JO - Ophthalmology VL - 120 IS - 11 N2 - OBJECTIVE: To evaluate the relative efficacy and safety profile of bevacizumab versus ranibizumab intravitreal injections for the treatment of neovascular age-related macular degeneration (AMD). DESIGN: Multicenter, prospective, noninferiority, double-masked, randomized clinical trial performed in 38 French ophthalmology centers. The noninferiority limit was 5 letters. PARTICIPANTS: Patients aged ≥50 years were eligible if they presented with subfoveal neovascular AMD, with best-corrected visual acuity (BVCA) in the study eye of between 20/32 and 20/320 measured on the Early Treatment of Diabetic Retinopathy Study chart and a lesion area of less than 12 optic disc areas (DA). METHODS: Patients were randomly assigned to intravitreal administration of bevacizumab (1.25 mg) or ranibizumab (0.50 mg). Hospital pharmacies were responsible for preparing, blinding, and dispensing treatments. Patients were followed for 1 year, with a loading dose of 3 monthly intravitreal injections, followed by an as-needed regimen (1 injection in case of active disease) for the remaining 9 months with monthly follow-up. MAIN OUTCOME MEASURES: Mean change in visual acuity at 1 year. RESULTS: Between June 2009 and November 2011, 501 patients were randomized. In the per protocol analysis, bevacizumab was noninferior to ranibizumab (bevacizumab minus ranibizumab +1.89 letters; 95% confidence interval [CI], -1.16 to +4.93, P < 0.0001). The intention-to-treat analysis was concordant. The mean number of injections was 6.8 in the bevacizumab group and 6.5 in the ranibizumab group (P = 0.39). Both drugs reduced the central subfield macular thickness, with a mean decrease of 95 μm for bevacizumab and 107 μm for ranibizumab (P = 0.27). There were no significant differences in the presence of subretinal or intraretinal fluid at final evaluation, dye leakage on angiogram, or change in choroidal neovascular area. The proportion of patients with serious adverse events was 12.6% in the bevacizumab group and 12.1% in the ranibizumab group (P = 0.88). The proportion of patients with serious systemic or ocular adverse events was similar in both groups. CONCLUSIONS: Bevacizumab was noninferior to ranibizumab for visual acuity at 1 year with similar safety profiles. Ranibizumab tended to have a better anatomic outcome. The results are similar to those of previous head-to-head studies. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/23916488/Ranibizumab_versus_Bevacizumab_for_Neovascular_Age_related_Macular_Degeneration:_Results_from_the_GEFAL_Noninferiority_Randomized_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(13)00524-1 DB - PRIME DP - Unbound Medicine ER -