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ANTI-VEGF TREATMENT IN NEOVASCULAR AGERELATED MACULAR DEGENERATION: A Treat-and-Extend Protocol Over 2 Years

Abedi, Farshad MD, DMedSc; Wickremasinghe, Sanjeewa FRCOphth, FRANZCO; Islam, Amirul F. M. PhD; Inglis, Kellie M. BHSc; Guymer, Robyn H. PhD, FRANZCO

doi: 10.1097/IAE.0000000000000134
Original Study

Purpose: To evaluate 2-year visual acuity outcome of a treat-and-extend protocol of anti–vascular endothelial growth factor treatment in age-related macular degeneration.

Methods: In this prospective cohort study, 120 age-related macular degeneration patients with choroidal neovascularization received 3 initial monthly ranibizumab or bevacizumab injections; monthly injections were continued until there was no choroidal neovascularization activity (subretinal/intraretinal fluid, loss of >5 letters, or persistent/recurrent retinal hemorrhage). When there was no choroidal neovascularization activity, the interval to the next visit/injection was extended by 2 weeks to a maximum of 12 weeks. In the presence of choroidal neovascularization activity, this interval was shortened by 2 weeks. Main outcome measures included the percentage losing <15 letters and the mean visual acuity change after 12 months and 24 months.

Results: Mean baseline visual acuity was 51.2 ± 12.1 Early Treatment Diabetic Retinopathy Study scores. Mean visual acuity change from baseline was +9.5 ± 10.9 and +8.0 ± 12.9 letters after 12 months and 24 months, respectively, with, on average, 8.6 ± 1.1 visits/injections in the first year and 5.6 ± 2.0 in the second year. After 12 months and 24 months, 97.5% and 95.0% of patients, respectively, lost <15 letters.

Conclusion: The “inject-and-extend” protocol—with fewer injections and visits—delivered outcomes comparable to those of the pivotal clinical trials of monthly ranibizumab.

In this prospective cohort study on 120 consecutive patients with neovascular age-related macular degeneration, a treat-and-extend protocol of anti–vascular endothelial growth factor treatment delivered visual outcomes similar to those of the pivotal clinical trials of monthly ranibizumab injections. This was achieved with fewer clinic visits and injections.

Center for Eye Research Australia, University of Melbourne, Royal Victorian Eye and Ear Hospital, Victoria, Australia.

Reprint requests: Farshad Abedi, MD, DMedSc, 3/5-13 Huchinson Street, Surry Hills 2010, Australia; e-mail: abedifarshad@yahoo.com

Supported by the National Health and Medical Research Council (NHMRC) project grants 590205 and 1008979, an NHMRC Clinical Research Excellence grant 529923, NHMRC practitioner fellowship (RHG), and NHMRC Fight Retinal Blindness (FRB) grant 632663. The Centre for Eye Research Australia (CERA) receives Operational Infrastructure Support from the Victorian Government. The sponsor or funding organizations had no role in the design or conduct of this research.

This work was partly presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, Seattle, WA, May, 2013.

Professor R. H. Guymer is a member of the advisory boards of Novartis (Australia) and Bayer (Australia). Dr. S. Wickremasinghe has received speaker fees from Novartis (Australia). Dr. F. Abedi, Dr. A. F. M. Islam, and Ms. K. M. Inglis had no proprietary interest.

© 2014 by Ophthalmic Communications Society, Inc.