Ranibizumab versus Verteporfin for Neovascular Age-Related Macular Degeneration

Brown, David M.; Kaiser, Peter K.; Michels, Mark; Soubrane, G.; Heier, Jeffrey S.; Kim, Robert Y.; Sy, Judy P.; Schneider, Susan

doi:10.1056/nejmoa062655

Cited by 3,239 publications

(2,533 citation statements)

References 15 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%

“…All enrolled patients were treatment‐naïve to anti‐VEGF. 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.…”

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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