Ranibizumab for Neovascular Age-Related Macular Degeneration

Rosenfeld, Philip J.; Brown, David M.; Heier, Jeffrey S.; Boyer, David S.; Kaiser, Peter K.; Chung, Carol; Kim, Robert Y.

doi:10.1056/nejmoa054481

Cited by 5,269 publications

(4,331 citation statements)

References 20 publications

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“…Data from four multicenter, randomized, double‐blinded, phase III, ranibizumab clinical studies—ANCHOR,7 MARINA,8 PIER15, and EXCITE16—were used to develop the model. All studies complied with the Declaration of Helsinki.…”

Section: Methodsmentioning

confidence: 99%

“…All studies complied with the Declaration of Helsinki. The methodology of these trials has been extensively described elsewhere 7, 8, 15, 16…”

Section: Methodsmentioning

confidence: 99%

“…The ANCHOR study compared the safety and efficacy of monthly ranibizumab (0.3 mg and 0.5 mg) to photodynamic therapy (PDT; verteporfin) 7. The MARINA study evaluated the efficacy of monthly dosing of ranibizumab 0.3 mg and 0.5 mg vs. sham,8 whereas the PIER study determined the efficacy of ranibizumab 0.3 mg and 0.5 mg once‐monthly for 3 months, then once‐quarterly vs. sham 15. The EXCITE study was an active‐controlled, three‐arm study of ranibizumab 0.3 mg or 0.5 mg once‐monthly for 3 months and then once‐quarterly vs. ranibizumab 0.3 mg once‐monthly (see Table 1).…”

Section: Methodsmentioning

confidence: 99%

“…Inhibition of VEGF causes neovessel regression and reduces vascular permeability, ultimately reducing the presence of pathological retinal fluid. Consequently, intraocular anti‐VEGF therapy greatly improves visual acuity (VA) in patients with nAMD 7, 8…”

mentioning

confidence: 99%

“…Previously, we developed a model for ranibizumab in patients with nAMD utilizing 1‐year data from the ANCHOR,7 MARINA,8 PIER15, and EXCITE16 clinical studies. This model supported treatment recommendations for optimal dosing and a label update approved by the European Medicines Agency (EMA) 17.…”

mentioning

confidence: 99%

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Neovascular Age‐Related Macular Degeneration: A Visual Acuity Model of Natural Disease Progression and Ranibizumab Treatment Effect

Mulyukov

Weber

Pigeolet

et al. 2018

CPT Pharmacom & Syst Pharma

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Intravitreal ranibizumab is a first‐line therapy for neovascular age‐related macular degeneration (nAMD), but there is a need to optimize patient outcomes while minimizing treatment burden. Here, we developed an indirect response, nonlinear, mixed effects model of disease progression and drug effect in anti‐vascular endothelial growth factor (VEGF) treatment‐naïve patients. A total of 1,524 treatment‐naïve patients and 29,754 visual acuity observations from the ANCHOR, MARINA, PIER, and EXCITE clinical trials informed the model. The model accurately described natural nAMD disease progression and predicted mean visual acuity gains in the HARBOR study, notably with a 2.0 mg ranibizumab dose not used for model development. Furthermore, individualized treatment regimens were shown by simulation to be a viable alternative to the commonly used pro re nata or fixed monthly dosing regimen approaches. Therefore, this model could be a useful tool to predict the outcomes of different, more patient‐tailored treatment regimens in nAMD.

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Section: Methodsmentioning

confidence: 99%

“…All studies complied with the Declaration of Helsinki. The methodology of these trials has been extensively described elsewhere 7, 8, 15, 16…”

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Neovascular Age‐Related Macular Degeneration: A Visual Acuity Model of Natural Disease Progression and Ranibizumab Treatment Effect

Mulyukov

Weber

Pigeolet

et al. 2018

CPT Pharmacom & Syst Pharma

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Folic Acid, Pyridoxine, and Cyanocobalamin Combination Treatment and Age-Related Macular Degeneration in Women

Christen¹,

Glynn²,

Chew³

et al. 2009

Arch Intern Med

151

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Context Observational epidemiologic studies indicate a direct association between homocysteine concentration in the blood and risk of age-related macular degeneration (AMD), but randomized trial data to examine the effect of homocysteine-lowering in AMD are lacking. Objective To examine incidence of AMD in a trial of folic acid/vitamin B6/vitamin B12. Design Randomized, double-masked, placebo-controlled trial. Participants 5,442 female health professionals aged 40 years or older with preexisting cardiovascular disease (CVD) or 3 or more CVD risk factors. A total of 5,205 of these women did not have a diagnosis of AMD at baseline and were included in this analysis. Intervention Participants were randomly assigned to receive a combination of folic acid (2.5 mg/d), vitamin B6 (50 mg/d), and vitamin B12 (1 mg/d), or placebo. Main Outcome Measures Total AMD, defined as a self-report documented by medical record evidence of an initial diagnosis after randomization, and visually-significant AMD, defined as confirmed incident AMD with visual acuity of 20/30 or worse attributable to this condition. Results After an average of 7.3 years of treatment and follow-up, there were 55 cases of AMD in the folic acid/B6/B12 group and 82 in the placebo group (relative risk [RR], 0.66; 95% confidence interval [CI], 0.47–0.93; p=0.02). For visually-significant AMD, there were 26 cases in the folic acid/B6/B12 group and 44 in the placebo group (RR, 0.59; 95% CI, 0.36–0.95; p=0.03). Conclusions These randomized trial data from a large cohort of women at high risk of CVD indicate that daily supplementation with folic acid/B6/B12 may reduce the risk of AMD.

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Ranibizumab Combined With Verteporfin Photodynamic Therapy in Neovascular Age-Related Macular Degeneration

Heier

Boyer²,

Ciulla³

et al. 2006

Arch Ophthalmol

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Ranibizumab for Neovascular Age-Related Macular Degeneration

Cited by 5,269 publications

References 20 publications

Neovascular Age‐Related Macular Degeneration: A Visual Acuity Model of Natural Disease Progression and Ranibizumab Treatment Effect

Neovascular Age‐Related Macular Degeneration: A Visual Acuity Model of Natural Disease Progression and Ranibizumab Treatment Effect

Folic Acid, Pyridoxine, and Cyanocobalamin Combination Treatment and Age-Related Macular Degeneration in Women

Ranibizumab Combined With Verteporfin Photodynamic Therapy in Neovascular Age-Related Macular Degeneration

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