A Study to Evaluate rhuFab V2 in Subjects With Minimally Classic or Occult Subfoveal Neovascular Macular Degeneration

Summary

The purpose of this study is to determine whether injections of rhuFab V2 into the eye can prevent vision loss in patients with age-related macular degeneration, and also to evaluate the safety of this treatment.

Timeline

Start

2003-03

Primary completion

—

Completion

2005-12

Publications

• Results Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.
• Results Suner IJ, Kokame GT, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3629-35. doi: 10.1167/iovs.08-3225. Epub 2009 Feb 28.
• Blodi BA, Domalpally A, Corkery E, Osborne A, Blotner S, Grzeschik SM, Gune S. Prevalence of Macular Atrophy in the MARINA Study of Ranibizumab versus Sham for Neovascular Age-Related Macular Degeneration. Ophthalmol Retina. 2023 Aug;7(8):661-671. doi: 10.1016/j.oret.2023.03.004. Epub 2023 Apr 22.
• Mollan SP, Fu DJ, Chuo CY, Gannon JG, Lee WH, Hopkins JJ, Hughes C, Denniston AK, Keane PA, Cantrell R. Predicting the immediate impact of national lockdown on neovascular age-related macular degeneration and associated visual morbidity: an INSIGHT Health Data Research Hub for Eye Health report. Br J Ophthalmol. 2023 Feb;107(2):267-274. doi: 10.1136/bjophthalmol-2021-319383. Epub 2021 Sep 13.
• Weinberg DV, Shapiro H, Ehrlich JS. Ranibizumab treatment outcomes in phakic versus pseudophakic eyes: an individual patient data analysis of 2 phase 3 trials. Ophthalmology. 2013 Jun;120(6):1278-82. doi: 10.1016/j.ophtha.2012.11.042. Epub 2013 Feb 28.
• Xu L, Lu T, Tuomi L, Jumbe N, Lu J, Eppler S, Kuebler P, Damico-Beyer LA, Joshi A. Pharmacokinetics of ranibizumab in patients with neovascular age-related macular degeneration: a population approach. Invest Ophthalmol Vis Sci. 2013 Mar 5;54(3):1616-24. doi: 10.1167/iovs.12-10260.
• Bressler NM, Chang TS, Varma R, Suner I, Lee P, Dolan CM, Ward J, Ianchulev T, Fine J. Driving ability reported by neovascular age-related macular degeneration patients after treatment with ranibizumab. Ophthalmology. 2013 Jan;120(1):160-8. doi: 10.1016/j.ophtha.2012.07.027. Epub 2012 Sep 23.
• Elshout M, van der Reis MI, Webers CA, La Heij EC, Hendrikse F, Schouten JS. A new epidemiological aid in deciding whether to continue or stop a treatment. Invest Ophthalmol Vis Sci. 2012 Jul 1;53(8):4331-6. doi: 10.1167/iovs.11-9242.
• Rosenfeld PJ, Shapiro H, Ehrlich JS, Wong P; MARINA and ANCHOR Study Groups. Cataract surgery in ranibizumab-treated patients with neovascular age-related macular degeneration from the phase 3 ANCHOR and MARINA trials. Am J Ophthalmol. 2011 Nov;152(5):793-8. doi: 10.1016/j.ajo.2011.04.025. Epub 2011 Jul 26.
• Hawkins BS, Bressler NM, Reynolds SM. Patient-reported outcomes among sham vs no-treatment controls from randomized trials. Arch Ophthalmol. 2011 Feb;129(2):200-5. doi: 10.1001/archophthalmol.2010.359.
• Rosenfeld PJ, Shapiro H, Tuomi L, Webster M, Elledge J, Blodi B; MARINA and ANCHOR Study Groups. Characteristics of patients losing vision after 2 years of monthly dosing in the phase III ranibizumab clinical trials. Ophthalmology. 2011 Mar;118(3):523-30. doi: 10.1016/j.ophtha.2010.07.011.
• Barbazetto I, Saroj N, Shapiro H, Wong P, Freund KB. Dosing regimen and the frequency of macular hemorrhages in neovascular age-related macular degeneration treated with ranibizumab. Retina. 2010 Oct;30(9):1376-85. doi: 10.1097/IAE.0b013e3181dcfb0b.
• Barbazetto IA, Saroj N, Shapiro H, Wong P, Ho AC, Freund KB. Incidence of new choroidal neovascularization in fellow eyes of patients treated in the MARINA and ANCHOR trials. Am J Ophthalmol. 2010 Jun;149(6):939-946.e1. doi: 10.1016/j.ajo.2010.01.007. Epub 2010 Apr 8.
• Bressler NM, Chang TS, Suner IJ, Fine JT, Dolan CM, Ward J, Ianchulev T; MARINA and ANCHOR Research Groups. Vision-related function after ranibizumab treatment by better- or worse-seeing eye: clinical trial results from MARINA and ANCHOR. Ophthalmology. 2010 Apr;117(4):747-56.e4. doi: 10.1016/j.ophtha.2009.09.002. Epub 2010 Mar 2.
• Chang TS, Bressler NM, Fine JT, Dolan CM, Ward J, Klesert TR; MARINA Study Group. Improved vision-related function after ranibizumab treatment of neovascular age-related macular degeneration: results of a randomized clinical trial. Arch Ophthalmol. 2007 Nov;125(11):1460-9. doi: 10.1001/archopht.125.11.1460.

Drugs

Indications