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Adrian H Koh, Boris Gekkiev, Ayan Das Gupta, Sue Lacey, ; Ranibizumab treatment and visual acuity outcomes in the presence or absence of pigment epithelium detachments: an interim analysis of the LUMINOUS study. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):1415.
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© ARVO (1962-2015); The Authors (2016-present)
To determine if the presence or absence of pigment epithelium detachments (PED) has an impact on the visual acuity (VA) outcomes of patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab in the LUMINOUS study.
LUMINOUS (clinicaltrials.gov; NCT01318941) is a prospective, 5-year, global, observational, multicenter study aiming to evaluate long-term safety, effectiveness and treatment patterns of intravitreal ranibizumab 0.5 mg in routine clinical practice across all approved indications. Initiated in March 2011, LUMINOUS is designed to recruit a total of 30,000 patients, with a minimum follow-up period of 12 months. The influence of baseline PED status (as assessed by the investigator in the primary treated eye) on VA outcomes and injection requirement was analyzed separately in both treatment naïve patients and those who were previously treated with ranibizumab. The analysis was conducted on the observed data set that included patients who had a baseline and 12-month VA assessment.
A total of 9,790 patients were recruited prior to March 2013, of whom 9,125 (93.2%) had nAMD; 1628 treatment naïve, 7454 previously treated with ranibizumab, 43 previously treated with other ocular treatments. Irrespective of baseline PED status, treatment naïve patients had lower mean baseline VA (±SD) [53.3 (18.24) and 53.7 (19.16) ETDRS letters] compared with those previously treated with ranibizumab [60.3 (17.23) and 59.6 (17.40) ETDRS letters]. At month 12, regardless of PED status at baseline, the mean VA (ETDRS letters) improved in treatment naïve patients (3.4 and 5.4) and was maintained in those previously treated with ranibizumab (-1.4 and -1.5, Table 1). These outcomes were achieved with a similar number of injections across all subgroups analyzed (4.3 to 4.8).
Irrespective of the presence or absence of PED, similar VA outcomes were attained at month 12 with nearly same numbers of ranibizumab injections in both treatment naïve patients and those previously treated with ranibizumab in nAMD.
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