Evaluation of the siRNA PF-04523655 versus ranibizumab for the treatment of neovascular age-related macular degeneration (MONET Study)

Quan Dong Nguyen, Ronald A. Schachar, Chudy I. Nduaka, Marvin Sperling, Karen J. Klamerus, Katherine Chi-Burris, Eric Yan, Dario A. Paggiarino, Irit Rosenblatt, Roger Aitchison, Shai S. Erlich

Research output: Contribution to journalArticle

Abstract

Objective: To evaluate the efficacy of different dosing paradigms of PF-04523655 (PF) versus ranibizumab (comparator) in subjects with neovascular age-related macular degeneration (AMD). Design: Multicenter, open-label, prospective, randomized, comparator-controlled exploratory study. Participants: A total of 151 patients with subfoveal choroidal neovascularization (CNV) secondary to neovascular AMD who were naive to AMD therapy. Methods: In this phase 2 study, patients were randomized to 1 of 5 treatment groups with equal ratio. All groups received ranibizumab 0.5 mg at baseline and (a) PF 1 mg every 4 weeks (Q4W) from week 4 to week 12; (b) PF 3 mg Q4W from week 4 to week 12; (c) PF 3 mg every 2 weeks (Q2W) from week 4 to week 12; (d) PF 1 mg + ranibizumab (combination) Q4W from baseline to week 12; and (e) ranibizumab Q4W to week 12. All study treatments were given as intravitreal injections. Main Outcome Measures: The primary end point was the mean change in best-corrected visual acuity (BCVA) from baseline at week 16; secondary end points included the percentage of patients gaining

Original languageEnglish (US)
Pages (from-to)1867-1873
Number of pages7
JournalOphthalmology
Volume119
Issue number9
DOIs
StatePublished - Sep 2012

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Macular Degeneration
Small Interfering RNA
Platelet Factor 3
Choroidal Neovascularization
Intravitreal Injections
Therapeutics
Visual Acuity
Outcome Assessment (Health Care)
Ranibizumab
PF-04523655

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Nguyen, Q. D., Schachar, R. A., Nduaka, C. I., Sperling, M., Klamerus, K. J., Chi-Burris, K., ... Erlich, S. S. (2012). Evaluation of the siRNA PF-04523655 versus ranibizumab for the treatment of neovascular age-related macular degeneration (MONET Study). Ophthalmology, 119(9), 1867-1873. https://doi.org/10.1016/j.ophtha.2012.03.043

Evaluation of the siRNA PF-04523655 versus ranibizumab for the treatment of neovascular age-related macular degeneration (MONET Study). / Nguyen, Quan Dong; Schachar, Ronald A.; Nduaka, Chudy I.; Sperling, Marvin; Klamerus, Karen J.; Chi-Burris, Katherine; Yan, Eric; Paggiarino, Dario A.; Rosenblatt, Irit; Aitchison, Roger; Erlich, Shai S.

In: Ophthalmology, Vol. 119, No. 9, 09.2012, p. 1867-1873.

Research output: Contribution to journalArticle

Nguyen, QD, Schachar, RA, Nduaka, CI, Sperling, M, Klamerus, KJ, Chi-Burris, K, Yan, E, Paggiarino, DA, Rosenblatt, I, Aitchison, R & Erlich, SS 2012, 'Evaluation of the siRNA PF-04523655 versus ranibizumab for the treatment of neovascular age-related macular degeneration (MONET Study)', Ophthalmology, vol. 119, no. 9, pp. 1867-1873. https://doi.org/10.1016/j.ophtha.2012.03.043
Nguyen, Quan Dong ; Schachar, Ronald A. ; Nduaka, Chudy I. ; Sperling, Marvin ; Klamerus, Karen J. ; Chi-Burris, Katherine ; Yan, Eric ; Paggiarino, Dario A. ; Rosenblatt, Irit ; Aitchison, Roger ; Erlich, Shai S. / Evaluation of the siRNA PF-04523655 versus ranibizumab for the treatment of neovascular age-related macular degeneration (MONET Study). In: Ophthalmology. 2012 ; Vol. 119, No. 9. pp. 1867-1873.
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