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Ajay Kumar Kumar Kotagiri, Maged Habib, Alex Stubbing-Moore, Dalvir Bajwa, Deepali Varma, Maria Teresa Sandinha, Jonathan Smith, David Steel; Are the initial treatment results of Ranibizumab for Diabetic Macular Oedema maintained at 1 year with Pro re nata protocol? A real life experience.. Invest. Ophthalmol. Vis. Sci. 2016;57(12):2099.
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© ARVO (1962-2015); The Authors (2016-present)
Various treatment protocols have been adopted for the use of Ranibizumab (RBZ) for diabetic macular oedema (DMO) based on published trial results. The utility of these regimes in real-life practice has not been reported . This study was conducted to evaluate the efficacy of RBZ Pro re nata (PRN) protocol at 1 year following a fixed loading dose and whether earlier visual acuity gains with RBZ treatment are maintained.
Observational study with prospectively collected real-life data using an electronic database on patients with DMO treated with RBZ. All patients received RBZ loading dose of fixed four monthly injections with two further monthly injections if needed. This is followed by PRN protocol with monthly monitoring visits and deferred laser treatment if required. Baseline demographic and clinical data were collected. Best corrected visual acuity (BCVA) together with central retinal thickness (CRT) was recorded each visit as well as injections needed.
100 eyes of 73 patients included. Mean baseline BCVA was 60.1 letters (Standard Deviation (SD)13.7), with mean CRT of 472 (SD 107.7). Following maximum of six fixed monthly loading doses, the mean change in BCVA was 6 letters with a reduction of CRT reduction of -141.6 microns. However, following PRN dosing at 1 year, BCVA deteriorated by 4.2 letters while CRT was maintained. There was a mean of 6.6 injections in the first year with an average follow up intervals of 7.5 weeks.
The real life experience of RBZ treatment with a PRN protocols for DMO struggles to reflect phase 3 trials results. BCVA gains by earlier fixed dosing are not maintained. This could be due to several factors, including capacity issues to allow monthly monitoring and timely treatment. In real life, planned fixed dosing or treat and extend protocols may be better options for delivering more effective care.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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