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Yit Yang, REPAIR Study Group; The REPAIR Study: Prospective, Multi-center Trial of ranibizumab in Choroidal Neovascularization due to Pathological Myopia - the 12 month Primary Endpoint. Invest. Ophthalmol. Vis. Sci. 2013;54(15):2838. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To provide safety and efficacy data in 65 patients treated with ranibizumab for visual impairment due to choroidal neovascularization(CNV) secondary to pathological myopia(PM).
Phase 2, prospective open label, single arm, multicentre, 12-month study, in eyes with active sub- or juxtafoveal myopic CNV treated with 1+ pro-re nata (PRN) of IVT 0.5mg ranibizumab,. Retreatment followed a standardized pragmatic algorithm that was primarily driven by OCT morphologic changes indicating active disease. The primary end point was the mean gain in ETDRS letters read from baseline visual acuity at 12 months and the study was adequately powered to detect a 10 or more letter gain.
The mean visual acuity gain of the 65 eyes of 65 patients enrolled was rapid with 8.7 letters gained at month1 increasing to 13.8 letters at month 12 (p<0.001 ) . 95.4% of patients lost less than 8 letters, and 36.9% gained 15 or more letters of visual acuity. Morphological improvements paralleled the visual acuity change with a mean reduction in central retinal thickness on OCT of 135 µm and a reduction in the proportion of eyes with centre involving intraretinal oedema and subretinal fluid from 87.7% to 7.8% and 67.7% to 7.8 % respectively by month 12.. The functional and structural benefits were obtained by a low number of injections to month 12 (mean 3.6, median 3) with 21% patients requiring only the one baseline treatment. No new safety concerns were identified and no retinal detachments occurred during the study.
Ranibizumab treatment for myopic CNV using a simple, predominantly OCT driven retreatment algorithm, improves visual acuity on average at 12 months, with low rates of serious ocular adverse events.
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