Photographic measures of cytomegalovirus retinitis as surrogates for visual outcomes in treated patients

Objective: To evaluate photographic measures of cytomegalovirus (CMV) retin itis as surrogate outcomes for changes in vision in patients with CMV retin itis related to the acquired immunodefiency syndrome. Methods: Data from 3 clinical trials of CMV retinitis treatments were analy zed. Two photographic assessments of retinitis in eyes involved at baseline were evaluated: progression (lesion border movement greater than or equal to 750 pm or occurrence of a new lesion) and change in area of retina invol ved with retinitis. Vision measures were decline in best-corrected visual a cuity and change in visual field. Photographic measures were evaluated as s urrogate outcomes based on 4 criteria: (1) association with vision measure; (2) ability to account for treatment-related differences in vision measure ; (3) data completeness; and (4) sample size requirements. Results: Data from 1001 involved eyes (666 patients) were analyzed. Progres sion and change in area involved were predictive of declines in vision meas ures, accounted for 50% and 66% of the treatment effect on visual field, an d were available from 93% and 64% of involved eyes, respectively. Sample si ze estimates for a clinical trial were smallest with progression as the des ign outcome. Conclusion: Progression and change in area involved met the first and secon d criteria for surrogate outcomes for visual field loss; a complete evaluat ion for visual acuity decline was not possible because treatment-related di fferences were not observed. Progression met the logistical and sample size criteria better than change in area of retina involved with retinitis.