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Farshad Abedi, Sanjeewa Wickramsinghe, Amirul Islam, Kellie Inglis, Robyn Guymer; Visual outcomes of an Inject and Extend protocol of intravitreal anti-vascular endothelial growth factor treatment in neovascular age-related macular degeneration over two years. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4174.
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To evaluate visual outcomes of an “Inject and Extend” protocol of intravitreal anti-vascular endothelial growth factor treatment for patients with neovascular age-related macular degeneration (AMD) over 24 months.
120 consecutive treatment-naïve patients with active subfoveal choroidal neovascularization (CNV) secondary to AMD, who were treated with intravitreal ranibizumab or bevacizumab using an “Inject and Extend” protocol over 24 months at the Royal Victorian Eye and Ear Hospital in Australia, were recruited to this study. Each patient received three initial monthly injections. Follow-up visits and injections were continued at monthly intervals until there was no sign of CNV activity (subretinal or intraretinal fluid on optical coherence tomography, loss of ≥5 letters in best corrected visual acuity [BCVA] or persistent or recurrent haemorrhage). Thereafter, the interval to the next follow-up visit and re-treatment was extended by two weeks out to a maximum of 12 weeks if there was no sign of recurrent CNV activity. The 12 weekly injections were continued until the end of the study period as long as there was no recurrence of CNV activity. In the presence of one or more signs of CNV activity at any visit, an injection was administered and the interval to the next follow-up visit was shortened by two weeks (from the last interval). The main outcome measure was the mean change in BCVA after 12 and 24 months and the number of injections required.
Mean (standard deviation [SD]) baseline BCVA was 51.2 (12.1) Early Treatment Diabetic Retinopathy Study letter scores. Mean (SD) change in BCVA from baseline was +9.5 (10.9) and +8.0 (12.9) letters after 12 and 24 months with, on average, 8.6 (SD, 1.1) injections and clinic visits in the first year and 5.6 (SD, 2.0) injections and clinic visits in the second year. After 12 and 24 months, 97.5% and 95.0% of patients lost fewer than 15 letters and 30.8% and 29.7% gained ≥15 letters from baseline, respectively.
The “Inject and Extend” protocol delivered visual outcomes comparable to those of the pivotal phase III clinical trials of monthly ranibizumab injections. This was achieved with a lower number of injections and clinic visits, reducing the risks and the treatment burden for patients, their carers and the health care providers.
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