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`ORIGINAL ARTICLE
`
`Randomized, Double-Masked, Sham-Controlled Trial of Ranibizumab
`for Neovascular Age-related Macular Degeneration: PIER Study Year
`1
`
`
`
`•
`•
`Carl D. Regillo David M. Brown Prema Abraham
`The PIER Study Group •
`Published: December 03, 2007 • DOI: https://doi.org/10.1016/j.ajo.2007.10.004
`
`• ...
`
`•
`Susan Schneider Naveed Shams
`
`References
`
`Biography
`
`Article info
`
`Related Articles
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`Purpose
`To evaluate the efficacy and safety of ranibizumab administered monthly for three months and then quarterly
`in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular
`degeneration (AMD).
`
`Design
`Phase IIIb, multicenter, randomized, double-masked, sham injection-controlled trial in patients with
`predominantly or minimally classic or occult with no classic CNV lesions.
`
`Methods
`Patients were randomized 1:1:1 to 0.3 mg ranibizumab (n = 60), 0.5 mg ranibizumab (n = 61), or sham (n =
`63) treatment groups. The primary efficacy endpoint was mean change from baseline visual acuity (VA) at
`month 12.
`
`Results
`Mean changes from baseline VA at 12 months were −16.3, −1.6, and −0.2 letters for the sham, 0.3 mg, and
`0.5 mg groups, respectively (P ≤ .0001, each ranibizumab dose vs sham). Ranibizumab arrested CNV
`growth and reduced leakage from CNV. However, the treatment effect declined in the ranibizumab groups
`during quarterly dosing (e.g., at three months the mean changes from baseline VA had been gains of 2.9 and
`4.3 letters for the 0.3 mg and 0.5 mg doses, respectively). Results of subgroups analyses of mean change
`from baseline VA at 12 months by baseline age, VA, and lesion characteristics were consistent with the
`overall results. Few serious ocular or nonocular adverse events occurred in any group.
`
`Conclusions
`Ranibizumab administered monthly for three months and then quarterly provided significant VA benefit to
`patients with AMD-related subfoveal CNV and was well tolerated. The incidence of serious ocular or
`nonocular adverse events was low.
`
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`References
`Rosenfeld P.J. • Brown D.M. • Heier J.S. • et al.
`Ranibizumab for neovascular age-related macular degeneration.
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`https://www.ajo.com/article/S0002-9394(07)00881-1/fulltext
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`1/4
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` VOLUME 145, ISSUE 2
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`P239-248.E5,
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`FEBRUARY 2008
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`Show all authors
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`Randomized, Double-Masked, Sham-Controlled Trial of Ranibizumab for Neovascular Age-related Macular Degeneration: PIER S…
`3/13/23, 8:58 PM
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`Biography
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`https://www.ajo.com/article/S0002-9394(07)00881-1/fulltext
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`2/4
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`Samsung Bioepis Exhibit 1023 Page 2
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`3/13/23, 8:58 PM
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`Randomized, Double-Masked, Sham-Controlled Trial of Ranibizumab for Neovascular Age-related Macular Degeneration: PIER S…
`
`Carl D. Regillo received his medical degree from Harvard and performed both his ophthalmology residency
`and vitreoretinal fellowship at Wills Eye Institute, Philadelphia, Pennsylvania. He is a prior Heed fellow and
`recipient of the American Academy of Ophthalmology Achievement and Senior Achievement Awards. Dr
`Regillo is currently the Director of the Wills Clinical Retina Research Unit, Professor of Ophthalmology at
`Thomas Jefferson University, and Chairman of the Academy Retina section of the Basic and Clinical Science
`Course.
`
`Article info
`Publication history
`Published online: December 03, 2007
`Accepted: October 5, 2007
`Footnotes
`Supplemental Material available at AJO.com.
`
`Identification
`DOI: https://doi.org/10.1016/j.ajo.2007.10.004
`
`Copyright
`© 2008 Elsevier Inc. Published by Elsevier Inc. All rights reserved.
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`Randomized, Double-Masked, Sham-Controlled Trial of Ranibizumab for Neovascular Age-related Macular Degeneration: PIER S…
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