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Adnan Tufail, REPAIR Study Group; The REPAIR Study: Prospective, Multi-center Trial of ranibizumab in Choroidal Neovascularization due to Pathological Myopia - Interim Analysis. Invest. Ophthalmol. Vis. Sci. 2012;53(14):6920.
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© ARVO (1962-2015); The Authors (2016-present)
This[L1] prospective, multi-center study of therapy with 1+ pro-re nata (PRN) 0.5mg ranibizumab with standardized retreatment criteria was performed to provide safety and efficacy data in patients treated with ranibizumab for choroidal neovascularization (CNV) due to pathological myopia (PM).[L1]Purpose
Data[L1] are from the planned interim analysis where 48/65 patients have completed up to Visit 8 (Mth 6). At baseline(BL) 91.7% of patients were caucasian, had a mean age of 56.8 yrs, mean VA of 58.6 letters (SD=14.63) and mean CRT of 365.5 µm (SD=111.60) , 91.5% had evidence of intraretinal oedema with centre involvement and 57.4% of intraretinal cysts. The primary objective is to evaluate the mean change BCVA from BL to Mth 12 in patients with CNV secondary to PM who are treated with 0.5mg ranibizumab, and the study continues.[L1]Methods
At[L1] mth 6 a mean of 2.9 ranibizumab inj were given (median of 2), with 29% requiring no further treatment beyond the initial inj. Mean VA improved by 12.18 letters (median= 6) and CRT reduced by a mean of 107.87µm (median = 90.0) 82.6% of patients demonstrated no evidence of intraretinal oedema or intraretinal cysts.Patient reported outcomes (PRO) were evaluated using the WBQ-12 and MacTSQ10 tools.WBQ-12 demonstrated maintenance of well-being, with a BL mean of 25.1 (SD 7.04) rising to 25.7 (SD 5.43) at 6 months (maximum score 36).MacTSQ score rose from 55.3 (SD 17.77) at month 1 to 58.2 (SD 17.37) at 6 months (maximum score 72).One case of culture negative endophthalmitis was reported. No new safety signals were identified.[L1]Results
This[L1] analysis shows that ranibizumab therapy leads to improvement in visual acuity in patients with choroidal neovascularization due to pathological myopia.PRO measures indicate that satisfaction with the treatment increased modestly, whilst well being was maintained.[L1]Conclusions
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