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Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol.
Ophthalmology 2015; 122(1):146-52O

Abstract

PURPOSE

To compare the efficacy and safety of bevacizumab versus ranibizumab when administered according to a treat-and-extend protocol for the treatment of neovascular age-related macular degeneration (AMD).

DESIGN

Multicenter, randomized, noninferiority trial with a noninferiority limit of 5 letters.

PARTICIPANTS

Patients aged ≥ 50 years with previously untreated neovascular AMD in 1 eye and best-corrected visual acuity (BCVA) between 20/25 and 20/320.

METHODS

Patients were randomly assigned to receive ranibizumab 0.5 mg or bevacizumab 1.25 mg intravitreal injections. Monthly injections were given until inactive disease was achieved. The patients were then followed with a gradual extension of treatment interval by 2 weeks at a time up to a maximum of 12 weeks. If signs of recurrent disease appeared, the treatment interval was shortened by 2 weeks at a time.

MAIN OUTCOME MEASURES

Change in visual acuity at 1 year.

RESULTS

Between March 2009 and July 2012, 441 patients were randomized at 10 ophthalmological centers in Norway. The 1-year visit was completed by 371 patients. In the per protocol analysis at 1 year, bevacizumab was equivalent to ranibizumab, with 7.9 and 8.2 mean letters gained, respectively (95% confidence interval [CI] of mean difference, -2.4 to 2.9; P = 0.845). The intention-to-treat analysis was concordant. There was no significant difference in measured central retinal thickness (CRT), with a mean decrease of -112 μm for bevacizumab and -120 μm for ranibizumab (95% CI of mean difference, -13 to 28; P = 0.460). There was a statistically significant difference (P = 0.001) between the drugs regarding the number of treatments: 8.9 for bevacizumab and 8.0 for ranibizumab. There were fewer arteriothrombotic events in the bevacizumab group (1.4%) than in the ranibizumab group (4.5%) (P = 0.050) and significantly more cardiac events in the ranibizumab group (P = 0.036). However, patients treated with ranibizumab more often had a history of myocardial infarction (P = 0.021).

CONCLUSIONS

Bevacizumab and ranibizumab had equivalent effects on visual acuity at 1 year when administered according to a treat-and-extend protocol. The visual acuity results at 1 year were comparable to those of other clinical trials with monthly treatment. The numbers of serious adverse events were small.

Authors+Show Affiliations

Department of Ophthalmology, Oslo University Hospital, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway.Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway; Department of Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Oslo, Norway.Department of Statistics, Epidemiology and Health Economy, Oslo University Hospital, Oslo, Norway.Department of Ophthalmology, Oslo University Hospital, Oslo, Norway; Faculty of Medicine, Institute of Clinical Medicine, University of Oslo, Oslo, Norway. Electronic address: ragnheib@medisin.uio.no.

Pub Type(s)

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

Language

eng

PubMed ID

25227499

Citation

Berg, Karina, et al. "Comparison of Ranibizumab and Bevacizumab for Neovascular Age-related Macular Degeneration According to LUCAS Treat-and-extend Protocol." Ophthalmology, vol. 122, no. 1, 2015, pp. 146-52.
Berg K, Pedersen TR, Sandvik L, et al. Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol. Ophthalmology. 2015;122(1):146-52.
Berg, K., Pedersen, T. R., Sandvik, L., & Bragadóttir, R. (2015). Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol. Ophthalmology, 122(1), pp. 146-52. doi:10.1016/j.ophtha.2014.07.041.
Berg K, et al. Comparison of Ranibizumab and Bevacizumab for Neovascular Age-related Macular Degeneration According to LUCAS Treat-and-extend Protocol. Ophthalmology. 2015;122(1):146-52. PubMed PMID: 25227499.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of ranibizumab and bevacizumab for neovascular age-related macular degeneration according to LUCAS treat-and-extend protocol. AU - Berg,Karina, AU - Pedersen,Terje R, AU - Sandvik,Leiv, AU - Bragadóttir,Ragnheiður, Y1 - 2014/09/13/ PY - 2014/05/01/received PY - 2014/05/27/revised PY - 2014/07/25/accepted PY - 2014/9/18/entrez PY - 2014/9/18/pubmed PY - 2015/3/13/medline SP - 146 EP - 52 JF - Ophthalmology JO - Ophthalmology VL - 122 IS - 1 N2 - PURPOSE: To compare the efficacy and safety of bevacizumab versus ranibizumab when administered according to a treat-and-extend protocol for the treatment of neovascular age-related macular degeneration (AMD). DESIGN: Multicenter, randomized, noninferiority trial with a noninferiority limit of 5 letters. PARTICIPANTS: Patients aged ≥ 50 years with previously untreated neovascular AMD in 1 eye and best-corrected visual acuity (BCVA) between 20/25 and 20/320. METHODS: Patients were randomly assigned to receive ranibizumab 0.5 mg or bevacizumab 1.25 mg intravitreal injections. Monthly injections were given until inactive disease was achieved. The patients were then followed with a gradual extension of treatment interval by 2 weeks at a time up to a maximum of 12 weeks. If signs of recurrent disease appeared, the treatment interval was shortened by 2 weeks at a time. MAIN OUTCOME MEASURES: Change in visual acuity at 1 year. RESULTS: Between March 2009 and July 2012, 441 patients were randomized at 10 ophthalmological centers in Norway. The 1-year visit was completed by 371 patients. In the per protocol analysis at 1 year, bevacizumab was equivalent to ranibizumab, with 7.9 and 8.2 mean letters gained, respectively (95% confidence interval [CI] of mean difference, -2.4 to 2.9; P = 0.845). The intention-to-treat analysis was concordant. There was no significant difference in measured central retinal thickness (CRT), with a mean decrease of -112 μm for bevacizumab and -120 μm for ranibizumab (95% CI of mean difference, -13 to 28; P = 0.460). There was a statistically significant difference (P = 0.001) between the drugs regarding the number of treatments: 8.9 for bevacizumab and 8.0 for ranibizumab. There were fewer arteriothrombotic events in the bevacizumab group (1.4%) than in the ranibizumab group (4.5%) (P = 0.050) and significantly more cardiac events in the ranibizumab group (P = 0.036). However, patients treated with ranibizumab more often had a history of myocardial infarction (P = 0.021). CONCLUSIONS: Bevacizumab and ranibizumab had equivalent effects on visual acuity at 1 year when administered according to a treat-and-extend protocol. The visual acuity results at 1 year were comparable to those of other clinical trials with monthly treatment. The numbers of serious adverse events were small. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/25227499/Comparison_of_ranibizumab_and_bevacizumab_for_neovascular_age_related_macular_degeneration_according_to_LUCAS_treat_and_extend_protocol_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(14)00685-X DB - PRIME DP - Unbound Medicine ER -