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Macular atrophy and hyperreflective material were common after 7 years of follow-up in IVAN trial.
New findings suggest that macular atrophy and hyperreflective material (HRM) were common after 7-years of follow-up in a cohort of participants who exited the Inhibition of VEGF in Age-Related Choroidal Neovascularization (IVAN) trial.
Led by Usha Chakravarthy, MD, PhD, Queen’s University of Belfast, the team of investigators aimed to describe the frequency of long-term morphologic features and their relationships with visual function in participants who exited the trial, with the multicenter cohort study following up to 7 years after enrollment.
The participants included those enrolled in the IVAN trial, excluding participants who died or withdrew during the trial. Investigators obtained multimodal fundus images, best-corrected visual acuity (BCVA), and low-luminance visual acuity (LLVA) for a subset of 199 participants who attended a research visit.
The 20 clinical sites provided all visual acuity and clinical information from usual care records for 532 participants and additionally submitted the most recent color, optical coherence tomography (OCT), and other fundus images for 468 participants to a reading center.
From recent images, investigators assessed intralesional macular atrophy (ILMA) within the footprint of the neovascular lesion, HRM, intraretinal fluid (IRF), subretinal fluid (SRF), pigment epithelial detachment (PED), and disorganized retinal outer layers (DROLs). They additionally estimated the cross-sectional relationships between morphological features and BCVA/LLVA.
Data show intralesional macular atrophy was present in 31.8% of the study eyes at IVAN exit, with a mean follow-up of 1.96 years. In comparison, it was present in 89.5% at the most recent imaging visit (mean follow-up, 6.18 years).
Moreover, investigators found hyperreflective material. IRF, SRF, PED, and DROLs in 78.8%, 47.7%, 7.6%, 94.5%, and 55% of the study eyes, respectively.
In eyes with complete imaging data and without DROL, the BCVA was noted as worse in the thinnest outer fovea tertile (thinnest minus middle and thickest tertiles, -19.7 and -19.5 letters, respectively). In eyes with DROL, the BCVA was worst in the thickest outer fovea tertile (thinnest and middle tertiles minus thickest, 12.5 and 12.2, respectively).
They added that the study’s regression models showed that the presence of ILMA and HRM was independently associated with BCVA (22 letters worse [95% confidence interval (CI), -11.2 to -32.8; P <.001] and 9.8 letters worse [95% CI, -0.1 to -19.4; P = .047], respectively).
The findings additionally suggest that subretinal fluid and foveal PED were associated with better BCVA (5.9 letters [95% CI, -7.9 to 19.7; P = .299] and 6.4 letters [95% CI, -1.1 to 14.0; P = .094], respectively).
“The model with LLVA was similar,” Chakravarthy noted. “A sensitivity analysis involving the entire eligible cohort yielded similar estimates.”
The study, “Long-term Retinal Morphology and Functional Associations in Treated Neovascular Age-Related Macular Degeneration: Findings from the Inhibition of VEGF in Age-Related Choroidal Neovascularisation Trial,” was published in Ophthalmology Retina.