A Variable-dosing Regimen with Intravitreal Ranibizumab for Neovascular Age-related Macular Degeneration: Year 2 of the PrONTO Study

Geeta A. Lalwani, Philip J Rosenfeld, Anne E. Fung, Sander Dubovy, Stephen Michels, William J Feuer, Janet L Davis, Harry W Flynn, Maria Esquiabro

Research output: Contribution to journalArticle

628 Citations (Scopus)

Abstract

Purpose: To assess the long-term efficacy of a variable-dosing regimen with ranibizumab in the Prospective Optical Coherence Tomography (OCT) Imaging of Patients with Neovascular Age-Related Macular Degeneration (AMD) Treated with intraOcular Ranibizumab (PrONTO) Study, patients were followed for 2 years. Design: A 2-year prospective, uncontrolled, variable-dosing regimen with intravitreal ranibizumab based on OCT. Methods: In this open-label, prospective, single-center, uncontrolled clinical study, AMD patients with neovascularization involving the central fovea and a central retinal thickness (CRT) of at least 300 μm as measured by OCT were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg) [Lucentis; Genentech Inc, South San Francisco, California, USA]. During the first year, retreatment with ranibizumab was performed at each monthly visit if any criterion was fulfilled such as an increase in OCT-CRT of at least 100 μm or a loss of 5 letters or more. During the second year, the retreatment criteria were amended to include retreatment if any qualitative increase in the amount of fluid was detected using OCT. Results: Forty patients were enrolled and 37 completed the 2-year study. At month 24, the mean visual acuity (VA) improved by 11.1 letters (P < .001) and the OCT-CRT decreased by 212 μm (P < .001). VA improved by 15 letters or more in 43% of patients. These VA and OCT outcomes were achieved with an average of 9.9 injections over 24 months. Conclusions: The PrONTO Study using an OCT-guided variable-dosing regimen with intravitreal ranibizumab resulted in VA outcomes comparable with the outcomes from the phase III clinical studies, but fewer intravitreal injections were required.

Original languageEnglish
JournalAmerican Journal of Ophthalmology
Volume148
Issue number1
DOIs
StatePublished - Jul 1 2009

Fingerprint

Optical Coherence Tomography
Visual Acuity
Retreatment
Intravitreal Injections
Macular Degeneration
San Francisco
Ranibizumab
Macular Degeneration, Age-Related, 2
varespladib methyl
Injections

ASJC Scopus subject areas

  • Ophthalmology

Cite this

A Variable-dosing Regimen with Intravitreal Ranibizumab for Neovascular Age-related Macular Degeneration : Year 2 of the PrONTO Study. / Lalwani, Geeta A.; Rosenfeld, Philip J; Fung, Anne E.; Dubovy, Sander; Michels, Stephen; Feuer, William J; Davis, Janet L; Flynn, Harry W; Esquiabro, Maria.

In: American Journal of Ophthalmology, Vol. 148, No. 1, 01.07.2009.

Research output: Contribution to journalArticle

@article{73ebff01e13c4ac58c5843889f8701e1,
title = "A Variable-dosing Regimen with Intravitreal Ranibizumab for Neovascular Age-related Macular Degeneration: Year 2 of the PrONTO Study",
abstract = "Purpose: To assess the long-term efficacy of a variable-dosing regimen with ranibizumab in the Prospective Optical Coherence Tomography (OCT) Imaging of Patients with Neovascular Age-Related Macular Degeneration (AMD) Treated with intraOcular Ranibizumab (PrONTO) Study, patients were followed for 2 years. Design: A 2-year prospective, uncontrolled, variable-dosing regimen with intravitreal ranibizumab based on OCT. Methods: In this open-label, prospective, single-center, uncontrolled clinical study, AMD patients with neovascularization involving the central fovea and a central retinal thickness (CRT) of at least 300 μm as measured by OCT were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg) [Lucentis; Genentech Inc, South San Francisco, California, USA]. During the first year, retreatment with ranibizumab was performed at each monthly visit if any criterion was fulfilled such as an increase in OCT-CRT of at least 100 μm or a loss of 5 letters or more. During the second year, the retreatment criteria were amended to include retreatment if any qualitative increase in the amount of fluid was detected using OCT. Results: Forty patients were enrolled and 37 completed the 2-year study. At month 24, the mean visual acuity (VA) improved by 11.1 letters (P < .001) and the OCT-CRT decreased by 212 μm (P < .001). VA improved by 15 letters or more in 43{\%} of patients. These VA and OCT outcomes were achieved with an average of 9.9 injections over 24 months. Conclusions: The PrONTO Study using an OCT-guided variable-dosing regimen with intravitreal ranibizumab resulted in VA outcomes comparable with the outcomes from the phase III clinical studies, but fewer intravitreal injections were required.",
author = "Lalwani, {Geeta A.} and Rosenfeld, {Philip J} and Fung, {Anne E.} and Sander Dubovy and Stephen Michels and Feuer, {William J} and Davis, {Janet L} and Flynn, {Harry W} and Maria Esquiabro",
year = "2009",
month = "7",
day = "1",
doi = "10.1016/j.ajo.2009.01.024",
language = "English",
volume = "148",
journal = "American Journal of Ophthalmology",
issn = "0002-9394",
publisher = "Elsevier USA",
number = "1",

}

TY - JOUR

T1 - A Variable-dosing Regimen with Intravitreal Ranibizumab for Neovascular Age-related Macular Degeneration

T2 - Year 2 of the PrONTO Study

AU - Lalwani, Geeta A.

AU - Rosenfeld, Philip J

AU - Fung, Anne E.

AU - Dubovy, Sander

AU - Michels, Stephen

AU - Feuer, William J

AU - Davis, Janet L

AU - Flynn, Harry W

AU - Esquiabro, Maria

PY - 2009/7/1

Y1 - 2009/7/1

N2 - Purpose: To assess the long-term efficacy of a variable-dosing regimen with ranibizumab in the Prospective Optical Coherence Tomography (OCT) Imaging of Patients with Neovascular Age-Related Macular Degeneration (AMD) Treated with intraOcular Ranibizumab (PrONTO) Study, patients were followed for 2 years. Design: A 2-year prospective, uncontrolled, variable-dosing regimen with intravitreal ranibizumab based on OCT. Methods: In this open-label, prospective, single-center, uncontrolled clinical study, AMD patients with neovascularization involving the central fovea and a central retinal thickness (CRT) of at least 300 μm as measured by OCT were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg) [Lucentis; Genentech Inc, South San Francisco, California, USA]. During the first year, retreatment with ranibizumab was performed at each monthly visit if any criterion was fulfilled such as an increase in OCT-CRT of at least 100 μm or a loss of 5 letters or more. During the second year, the retreatment criteria were amended to include retreatment if any qualitative increase in the amount of fluid was detected using OCT. Results: Forty patients were enrolled and 37 completed the 2-year study. At month 24, the mean visual acuity (VA) improved by 11.1 letters (P < .001) and the OCT-CRT decreased by 212 μm (P < .001). VA improved by 15 letters or more in 43% of patients. These VA and OCT outcomes were achieved with an average of 9.9 injections over 24 months. Conclusions: The PrONTO Study using an OCT-guided variable-dosing regimen with intravitreal ranibizumab resulted in VA outcomes comparable with the outcomes from the phase III clinical studies, but fewer intravitreal injections were required.

AB - Purpose: To assess the long-term efficacy of a variable-dosing regimen with ranibizumab in the Prospective Optical Coherence Tomography (OCT) Imaging of Patients with Neovascular Age-Related Macular Degeneration (AMD) Treated with intraOcular Ranibizumab (PrONTO) Study, patients were followed for 2 years. Design: A 2-year prospective, uncontrolled, variable-dosing regimen with intravitreal ranibizumab based on OCT. Methods: In this open-label, prospective, single-center, uncontrolled clinical study, AMD patients with neovascularization involving the central fovea and a central retinal thickness (CRT) of at least 300 μm as measured by OCT were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg) [Lucentis; Genentech Inc, South San Francisco, California, USA]. During the first year, retreatment with ranibizumab was performed at each monthly visit if any criterion was fulfilled such as an increase in OCT-CRT of at least 100 μm or a loss of 5 letters or more. During the second year, the retreatment criteria were amended to include retreatment if any qualitative increase in the amount of fluid was detected using OCT. Results: Forty patients were enrolled and 37 completed the 2-year study. At month 24, the mean visual acuity (VA) improved by 11.1 letters (P < .001) and the OCT-CRT decreased by 212 μm (P < .001). VA improved by 15 letters or more in 43% of patients. These VA and OCT outcomes were achieved with an average of 9.9 injections over 24 months. Conclusions: The PrONTO Study using an OCT-guided variable-dosing regimen with intravitreal ranibizumab resulted in VA outcomes comparable with the outcomes from the phase III clinical studies, but fewer intravitreal injections were required.

UR - http://www.scopus.com/inward/record.url?scp=67149101784&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=67149101784&partnerID=8YFLogxK

U2 - 10.1016/j.ajo.2009.01.024

DO - 10.1016/j.ajo.2009.01.024

M3 - Article

C2 - 19376495

AN - SCOPUS:67149101784

VL - 148

JO - American Journal of Ophthalmology

JF - American Journal of Ophthalmology

SN - 0002-9394

IS - 1

ER -