Purpose
To compare baseline characteristics, visual acuity (VA) and
morphological outcomes between eyes with baseline hard exudates (HE) and all
other eyes among patients with neovascular age-related macular degeneration
(NVAMD) treated with anti-vascular endothelial growth factors
(anti-VEGF).
Design
Prospective cohort study within the Comparison of Age-Related Macular
Degeneration Treatments Trials (CATT).
Participants
Patients with NVAMD.
Methods
Readers evaluated baseline and follow-up morphology on digital color
images, fluorescein angiography (FA), and optical coherence tomography (OCT)
in eyes with NVAMD that were randomly assigned to treatment with either
ranibizumab or bevacizumab. Ophthalmologists identified HE on color images
in the study eye.
Main Outcome Measures
VA; scar; geographic atrophy; retinal thickness, fluid; and number of
anti-VEGF injections.
Results
HE was present in 128 of 1185 (11%) study eyes at baseline,
77% within 1 disc diameter of the foveal center. Patients with study
eye HE were more likely female (81% vs 60%; p<0.001)
and non-smokers (53% vs 42%; p=0.004). Both groups had
similar proportions of hypercholesterolemia and hypertriglyceridemia. At
baseline, eyes with HE had worse VA (mean 57 vs 61 letters; p=0.003), larger
total lesion size (3.3 vs 2.4 DA; p <0.001), greater total foveal
thickness (522µm vs 452µm; p<0.001), more retinal
angiomatous proliferation (18% vs 10%; p=0.009) and sub-RPE
fluid (65% vs 47%; p<0.001). At 1 year, VA was
similar in both groups; more eyes with baseline HE had no fluid (45%
vs 29%; p<0.001) and greater reduction in total foveal
thickness (−266µm vs −158u; p<0.001). VA at
year 2 was similar but retinas of eyes with baseline HE were thinner
(267µm vs 299µm; p=0.03) and fewer eyes had sub-retinal
fluid (23% vs 36%; p=0.008). HE was present in 19%
of eyes at 1 year and 5% of eyes at 2 years. LIPC promoter SNP
rs10468017 was not associated with NVAMD HE.
Conclusion
Eyes with HE have larger CNV lesions and more RAP. Their initially
thicker retina rapidly becomes thinner on anti-VEGF treatment. HE is not
significantly associated with hyperlipidemia. HE at baseline does not
significantly influence VA, scar and GA outcomes in eyes with NVAMD treated
with anti-VEGF. Few eyes have HE at year 2.