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J.A. Elledge, M.K. W. Webster, M. Altaweel, M. Goldbaum, E.T. Cunningham, M.D. Davis, B. Katz; Alternative Measures of Fluorescein Leakage in the Angiographic Evaluation of Eyes With AMD: Experience of the Wisconsin Reading Center and the V.I.S.I.O.N. Trials . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5692.
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© ARVO (1962-2015); The Authors (2016-present)
To compare alternative methods of assessing fluoresceinleakage in eyes with neovascular Age–Related Macular Degeneration.
565 participants in the 2 V.I.S.I.O.N. trials comparingusual care (n=276) and 0.3mg Pegaptanib Sodium (Macugen®)(n=280) were evaluated at baseline and week 54. Leakage in thefluorescein angiogram was documented using 2 methods: a) the2– dimensional area of leakage was determined in discareas at each visit, and b) baseline and week 54 images weredirectly compared to allow a global estimate of change in leakage(a combination of area and intensity) from baseline: substantially,definitely or questionably less leakage; leakage the same; orquestionably, definitely, or substantially more leakage. Graderswere masked to treatment group and to gradings by the alternativemethod.
*average diameter of leakage area in disc diameters (DD)
The global comparison, which takes into accountintensity as well as area of leakage, supports the findingsof direct measurement of leakage area. Both methods supportthe primary visual outcome of the trials. The global assessmentmethod correlates more highly with the visual acuity endpointwith a statistically significant benefit for the 0.3mg groupvs. sham at the primary endpoint, and is more intuitively obviousto clinicians. This method will be incorportated into futureclinical trials evaluating exudative AMD to supplement our abilityto evaluate lesion activity and correlate morphologic and visualacuity endpoints.
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