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K. A. Muldrew, A. Milburn, U. Chakravarthy, G. Staurenghi, R. Buggage, The PERSPECTIVES Study Group; Baseline Fluorescein Angiographic Characteristics of Participants Enrolled in the PERSPECTIVES Study. Invest. Ophthalmol. Vis. Sci. 2008;49(13):5573.
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To describe the baseline fluorescein angiographic features of subjects enrolled in the PERSEPCTIVES study, a 102 week open-label multicentre trial of subjects with neovascular AMD, as determined by the Central Angiographic Resource Facility, the study reading centre.
Choroidal neovascular (CNV) lesions were categorized as early or established based on a combination of visual acuity and lesion characteristics on retinal imaging. Criteria for assignment to early lesions were visual acuity ≥ 54 letters and evidence of occult or minimally classic CNV with absence of all of the following features: subfoveal hemorrhage, hemorrhage measuring ≥1/2 DA in aggregate, lipid exudation, fibrosis, scar or atrophy and retinal pigment epithelial detachment. Criteria for established lesions were predominantly or minimally classic or occult with no classic subtypes if demonstrating any feature required to be absent from early lesions. Assignment to these categories was made by investigators and then independently verified at the reading centre. Patients with lesions exhibiting subfoveal fibrosis/atrophy or hemorrhage >50% of the total lesion were ineligible.
Of the 201 baseline angiograms reviewed by the reading centre 131 were assigned to the established and 70 to the early lesion strata by study investigators. 56 angiograms were classified by the reading centre as ineligible. Reasons for ineligibility included diagnosis not AMD (n=25), hemorrhage >50% of the total lesion size (n=13) and subfoveal fibrosis/atrophy (n=11). Only 17 lesions were graded as early CNV lesions by the reading centre (mean size 1.2 DA, median 0.86 DA). Of these 10 were subfoveal, 6 were juxtafoveal and 1 extrafoveal. Eight were classified as late leakage of indeterminate source. Of the 128 established CNV lesions 51% were occult with no classic (mean size 2.4 DA, median 1.5 DA).
Review of the baseline fluorescein angiographic features reveals marked discrepancies in subject strata assignment between study investigators and the reading centre. The phenotype distribution of CNV lesions was similar to that reported in published studies. The relatively low number of eyes that were classified as early lesions supports the view that such patients are less likely to present for treatment as visual function may at this stage be relatively good.
Clinical Trial: :
www.clinicaltrials.gov NCT00327470 A5751017
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