Ophthalmology · 2026
Vision-Related Quality of Life in Geographic Atrophy: Association with Topographic Lesion Distribution.
СтатьяКлиническое исследование III фазыРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Anegondi Neha, Lam Diana, Guymer Robyn H, Steffen Verena, Cukras Catherine A, Ferrara Daniela, Wu Zhichao
Аннотация
PURPOSE: To understand the associations between the topographic lesion distribution and vision-related quality of life (VR-QoL) in individuals with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
DESIGN: Analysis of data from Chroma (NCT02247479) and Spectri (NCT02247531), which are identically designed Phase III clinical trials of lampalizumab.
PARTICIPANTS: A total of 856 participants who were aged 50 years or more with bilateral GA who completed the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) at baseline.
METHODS: The NEI VFQ-25 was used to determine estimates of VR-QoL in the visual functioning (NEI VFQ-VF) domain, using calibrated item measures and rating category thresholds from the Rasch analysis. Geographic atrophy was automatically segmented on combined fundus autofluorescence and near-infrared reflectance images, and its extent in central regions across varying diameters (from 0.25 to 6.00 mm, in 0.25-mm intervals) relative to the fovea were then derived.
MAIN OUTCOME MEASURES: Association between NEI VFQ-VF person measures and the minimum eye-level GA extent in the region evaluated within an individual (referred to as the "minimum GA extent").
RESULTS: Minimum GA extent within the central region across varying diameters between 0.25 and 6.00 mm were all significantly associated with the NEI VFQ-VF person measures (P ≤ 0.001 for all), but the highest proportion of variance explained was seen when evaluating the central 2.50-mm diameter region (R2 = 0.11). A multivariable analysis showed that only the minimum GA extent within the central 2.50-mm region (P < 0.001), but not the 2.50- to 6.00-mm annulus (P = 0.541), was independently associated with NEI VFQ-VF person measures.
CONCLUSIONS: In this cohort, VR-QoL is most strongly associated with minimum eye-level GA extent within the central 2.50-mm region within an individual. These findings underscore the importance of evaluating GA extent in this region, beyond simply considering foveal GA involvement, when seeking to evaluate structural changes most closely associated with self-reported impairments in visual functioning.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
DESIGN: Analysis of data from Chroma (NCT02247479) and Spectri (NCT02247531), which are identically designed Phase III clinical trials of lampalizumab.
PARTICIPANTS: A total of 856 participants who were aged 50 years or more with bilateral GA who completed the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) at baseline.
METHODS: The NEI VFQ-25 was used to determine estimates of VR-QoL in the visual functioning (NEI VFQ-VF) domain, using calibrated item measures and rating category thresholds from the Rasch analysis. Geographic atrophy was automatically segmented on combined fundus autofluorescence and near-infrared reflectance images, and its extent in central regions across varying diameters (from 0.25 to 6.00 mm, in 0.25-mm intervals) relative to the fovea were then derived.
MAIN OUTCOME MEASURES: Association between NEI VFQ-VF person measures and the minimum eye-level GA extent in the region evaluated within an individual (referred to as the "minimum GA extent").
RESULTS: Minimum GA extent within the central region across varying diameters between 0.25 and 6.00 mm were all significantly associated with the NEI VFQ-VF person measures (P ≤ 0.001 for all), but the highest proportion of variance explained was seen when evaluating the central 2.50-mm diameter region (R2 = 0.11). A multivariable analysis showed that only the minimum GA extent within the central 2.50-mm region (P < 0.001), but not the 2.50- to 6.00-mm annulus (P = 0.541), was independently associated with NEI VFQ-VF person measures.
CONCLUSIONS: In this cohort, VR-QoL is most strongly associated with minimum eye-level GA extent within the central 2.50-mm region within an individual. These findings underscore the importance of evaluating GA extent in this region, beyond simply considering foveal GA involvement, when seeking to evaluate structural changes most closely associated with self-reported impairments in visual functioning.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.