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Arch Ophthalmol. 2001;119:554-563.

Objective  To evaluate photographic measures of cytomegalovirus (CMV) retinitis as surrogate outcomes for changes in vision in patients with CMV retinitis related to the acquired immunodefiency syndrome.

Methods  Data from 3 clinical trials of CMV retinitis treatments were analyzed. Two photographic assessments of retinitis in eyes involved at baseline were evaluated: progression (lesion border movement 750 µm or occurrence of a new lesion) and change in area of retina involved with retinitis. Vision measures were decline in best-corrected visual acuity and change in visual field. Photographic measures were evaluated as surrogate 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. Progression and change in area involved were predictive of declines in vision measures, accounted for 50% and 66% of the treatment effect on visual field, and were available from 93% and 64% of involved eyes, respectively. Sample size estimates for a clinical trial were smallest with progression as the design outcome.

Conclusion  Progression and change in area involved met the first and second criteria for surrogate outcomes for visual field loss; a complete evaluation for visual acuity decline was not possible because treatment-related differences were not observed. Progression met the logistical and sample size criteria better than change in area of retina involved with retinitis.

Janet T. Holbrook, PhD, MPH; Curtis L. Meinert, PhD; Mark L. Van Natta, MHS; Matthew Davis, MD; Larry Hubbard, MA; Douglas A. Jabs, MD, MBA; for the Studies of Ocular Complications of AIDS Research Group
From the Center for Clinical Trials (Drs Holbrook and Meinert and Mr Van Natta) and the Departments of Ophthalmology and Medicine (Dr Jabs), Johns Hopkins University, Baltimore, Md; and the Fundus Photograph Reading Center, University of Wisconsin, Madison (Dr Davis and Mr Hubbard).

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