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Marc C. Peden, Ronald E P Frenkel, Howard Shapiro, Ivaylo Stoilov; Visual acuity impairment under low luminance conditions at baseline is a powerful predictor of visual acuity response to ranibizumab therapy in patients with neovascular age-related macular degeneration. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):5362.
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To explore the impact of the baseline difference in visual acuity measured in normal and low luminance conditions (BCVA-LLVA gap) on the capacity of patients with neovascular age-related macular degeneration (AMD) to gain vision with ranibizumab therapy.
The HARBOR study (NCT00891735) evaluated the efficacy and safety of intravitreal ranibizumab 0.5 mg and 2.0 mg given monthly or as-needed (PRN) in patients with neovascular AMD. LLVA was measured by placing a 2.0-log-unit neutral density filter in front of the study eye and having the participant read the normally illuminated ETDRS chart. For this analysis, the study participants (N=1084) were pooled and divided into quartiles based on the magnitude of the BCVA-LLVA gap at baseline. The association between BCVA-LLVA gap and BCVA gains was analyzed using a general linear model.
The baseline BCVA-LLVA gap was negatively correlated with BCVA gain at Month 24 (P<0.0001); the significant association remained after controlling for baseline BCVA, as well as after stratifying by ranibizumab treatment group (0.5 mg or 2.0 mg; monthly or PRN). Patients with the narrowest BCVA-LLVA gap (smallest difference in vision under low luminance) at baseline gained, on average, 13.4 letters in BCVA at Month 24 (versus 2.4 letters in patients with the widest BCVA-LLVA gap at baseline) (Figure). Almost twice as many patients with the smallest baseline BCVA-LLVA gap gained ≥15 letters at Month 24 (49%) compared with patients with the widest baseline BCVA-LLVA gap (26%). Patients with the widest BCVA-LLVA gap at baseline also had the greatest PED, lesion, CNV and subretinal fluid thickness at baseline (P<0.05, based on a general linear model).
The BCVA-LLVA gap at baseline was prognostic for treatment response in patients with neovascular AMD. A narrow BCVA-LLVA gap may be a manifestation of milder retinal impairment and a predictor of greater capacity for visual function recovery with ranibizumab therapy. There is a good association between function as measured by the baseline visual gap and structure as measured by baseline OCT.
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