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Romeela Layale Rana-Rahman, Ajay Kotagiri, Maged Habib, Jonothan Smith, Sandhina Teresa, David Steel, Deepali Varma, ; Real life clinical audit on Neo-vascular age related macular degeneration (nAMD) - comparing fixed dose Aflibercept versus PRN Ranibizumab (RBZ) over 12 months.. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4618.
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© ARVO (1962-2015); The Authors (2016-present)
Multicentre clinical trials (VIEW 1&2) have demonstrated the efficacy of Aflibercept using fixed dose regimen for Aflibercept in the year one management of nAMD. There is limited real life data in the UK comparing results from benchmark clinical trials to actual clinical practice and for which regimen offers the best treatment outcome among patients treated with RBZ versus Aflibercept. This analysis evaluates the year one visual acuity (VA) results of Aflibercept versus RBZ in the management of treatment naïve nAMD patients.
Data on 100 consecutive treatment naïve eyes receiving treatment with Intra-vitreal Aflibercept who completed one year fixed dosing regimen (2013-2014). The Aflibercept regimen adhered to the VIEW study protocol of three monthly doses, followed by treatment every other month. 360 consecutive eyes were treated with PRN Intra-vitreal RBZ regimen after three loading doses (2011-2013). The outcome measures where vision at 12 months. Data was prospectively collated and compared. Exclusion criteria were patients who did not complete the 12 months treatment or who had developed other diseases. Treatment and follow up was at the same unit Sunderland Eye Infirmary (SEI).
100 eyes of 96 patients were included in the Aflibercept group. The mean letter gain after one year was 3.6 letters in the Aflibercept group Vs 3.9 letters in the RBZ group. Aflibercept patients received 7 injections each, versus the RBZ group received a mean of 5.4 in 12 months. 20% of the Aflibercept group (n=20) gained >15 letters, compared to 7.2% (n=26) eyes treated with RBZ. 96.7% eyes achieved stability of vision in the RBZ group compared to 92% in the Aflibercept group. 72% of the eyes treated with Aflibercept had no fluid detected on the OCT at the end of one year. 72% of the patients had no fluid detected on the OCT at the end of one year in the Aflibercept group.
The real life outcomes in nAMD patients treated with either PRN RBZ or Fixed dose Aflibercept at our unit are comparable to those achieved in clinical trials with respect to stabilisation of VA; even though less VA gain was noted in clinical practice after one year of treatment. There were significantly more number of patients gaining >15 letters in the Aflibercept group.
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