Photographic Measures of Cytomegalovirus Retinitis as Surrogates for Visual Outcomes in Treated Patients

Abstract

PIVOTAL EFFICACY trials supporting the approval of treatments for cytomegalovirus(CMV) retinitis were designed to compare time to retinitis progression as assessed from photographs between patients randomly assigned to immediate treatment or to deferral of treatment.^1-6 Retinitis progression was defined as 750 µm or more of movement along the border of an existing lesion or the appearance of a new lesion in either eye. Assessments of progression made from photographs by graders unaware of treatment assignment have proven to be a more reliable and sensitive method than assessments made by clinicians based on ophthalmoscopic examinations.^2,7,8 Movement of 750 µm or more is a sensitive measure of retinitis advancement selected to protect patients assigned to deferral of therapy from clinically important vision loss.