OSLI Retina

March/April 2013

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■ C L I N I C A L S C I E N C E ■ SAVE (Super-dose Anti-VEGF) Trial: 2.0 mg Ranibizumab for Recalcitrant Neovascular Age-Related Macular Degeneration: 1-Year Results Charles C. Wykoff, MD, PhD; David M. Brown, MD; Eric Chen, MD; James C. Major, MD, PhD; Daniel E. Croft, BA; Angeline Mariani, BA; Tien P. Wong, MD; SAVE Study Group INTRODUCTION OBJECTIVES: To assess durability of visual and anatomic gains with 2.0 mg ranibizumab in recalcitrant neovascular age-related macular degeneration (AMD). METHODS: Phase I-II trial of 88 patients with recalcitrant neovascular AMD treated as needed every 4 (cohort A) or 6 weeks (cohort B) following three monthly doses. ETDRS refraction and spectral-domain OCT–guided as-needed re-treatments. RESULTS: Seventy-nine patients completed the 12-month endpoint and were given 11.6 (cohort A) and 8.6 (cohort B) mean treatments. Mean best corrected visual acuity gains of 4.1 letters following three monthly doses were sustained for 12 months for both cohorts. Anatomic improvements were sustained for 12 months for cohort A, but not for cohort B; cohort B demonstrated a gradual increase in mean central retinal thickness (P = .03). CONCLUSION: Visual and anatomic gains achieved with 2.0 mg ranibizumab in recalcitrant neovascular AMD were sustained for 1 year with monthly treatment. In comparison, anatomic gains were diminished with less than monthly treatment. [Ophthalmic Surg Lasers Imaging Retina. 2013;44:121-126] EXPEDITED REVIEW Age-related macular degeneration (AMD) is a leading cause of vision loss.1 Most blindness associated with AMD is due to its neovascular form.2 Pharmaceutical agents that block vascular endothelial growth factor (VEGF) have revolutionized the management of neovascular AMD, and clinical blockade of VEGF by intravitreal injection of Lucentis (ranibizumab; Genentech, South San Francisco, CA),3,4 Avastin (bevacizumab; Genentech, South San Francisco, CA),5 or Eylea (aflibercept; Regeneron, Tarrytown, NJ)6 is remarkably effective. Nevertheless, many patients prescribed fixedinterval dosing with anti-VEGF agents manifest recalcitrant fluid. For example, in the Comparison of Age-related Macular Degeneration Treatment Trial (CATT), despite monthly treatment with anti-VEGF agents for 1 year, 53.2% of patients treated with ranibizumab and 70.9% of patients given bevacizumab showed evidence of persistent fluid on time-domain optical coherence tomography (OCT).7 Evidence suggests that some of these patients may benefit from a higher dose of anti-VEGF medications, an effect that may be particularly important in eyes considered incomplete responders, defined as eyes showing persistent exudation despite monthly treatment. Delivery of a higher dose of a given medication can be achieved in two manners. More frequent dosing can markedly improve through drug binding activity while having minimal impact on peak binding activity; this theory has been successfully applied with dos- From the Retina Consultants of Houston, the Methodist Hospital, Houston, Texas. Originally submitted February 15, 2013. Accepted for publication February 20, 2013. The authors received a research grant from Genentech. The funding organization had no role in the design or conduct of this research. Address correspondence to Charles C. Wykoff, MD, PhD, 6560 Fannin Street, Suite 750, Houston, TX 77030; 713-524-3434, Fax: 713-524-3220; Email: ccwmd@houstonretina.com. doi: 10.3928/23258160-20130313-04 March/April 2013 • Vol. 44, No. 2 121

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