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K. Hunter, E.L. Thomas, N.J. Rudometkin; Clinical Trials in Age–related Macular Degeneration (AMD) Are Not Comparable Based on Entry Visual Acuity and Lesion–size Measurement Techniques . Invest. Ophthalmol. Vis. Sci. 2005;46(13):2427.
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To compare entry criteria for vision and lesion–size measurement techniques for published and in–progress AMD clinical trials and to demonstrate lack of comparability among these trials.
Protocol descriptions of entry criteria for vision and lesion–size measurement techniques for trials using verteporfin, SnET2, anacortaave, ranibizumab, pegatanib, apharesis and squalamine clinical trials in AMD are presented.
Of the 14 major AMD clinical trials reviewed, entry criteria for vision assessment differed in 8 (See Table for variable ranges of entry criteria visual acuities). Lesion–size measurement techniques differ in these studies depending on four differing measurement techniques for optic disc diameter (DD). DD defined lesion size in disc–areas based on either an assumed disc–diameter (1.5 mm, 1.8 mm or 1.93 mm) or by measuring each individual DD. Depending which of the assumed disc–diameters used by different reading centers, a lesion–size discrepancy of up to 69% smaller to up to 66 % larger can be found. These variables create a significant source of discrepancy when attempting to compare results of clinical trials in AMD.
Variability in vision entry criteria and lesion–size measurement techniques for AMD clinical trials create difficulty in comparison of results of these studies.
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