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Outcomes Potentially Relevant to Management—TAP Report No. 6

Susan B. Bressler, MD; Dante J. Pieramici, MD; John M. Koester, MS; Neil M. Bressler, MD; for the TAP Study Group

Arch Ophthalmol. 2004;122:325-329.

Objective  To determine if there is a rationale for monitoring patients with age-related macular degeneration who have a minimally classic subfoveal choroidal neovascular lesion and do not receive treatment at initial examination.

Methods  Participants assigned to placebo who had a minimally classic lesion composition at baseline were identified from the TAP Investigation. Fluorescein angiograms at baseline and follow-up examinations from these participants were reviewed by photograph reading center graders to determine if any follow-up angiograms had converted from a minimally classic lesion composition to a predominantly classic lesion composition.

Main Outcome Measures  Proportion of minimally classic lesions at baseline that converted to a predominantly classic lesion composition, time of this conversion, and visual acuity and lesion size at the time of conversion.

Results  Of the 207 patients assigned to placebo in the TAP Investigation, 98 were judged to have a minimally classic lesion at baseline in the study eye when the fluorescein angiograms were reviewed in 2001. Of these 98 patients, 39 (40%) had lesions that converted to a predominantly classic lesion composition, including 21 by the month 3 examination. At the time of conversion, 32 (82%) lesions were no greater than 9 disc areas, including 20 (51%) with visual acuity of 20/200 or better.

Conclusions  These data would suggest that patients with minimally classic lesions, in whom no therapy is recommended initially, should be monitored so that potential conversion to a predominantly classic lesion can be identified promptly and verteporfin therapy considered.

From The Retinal Vascular Center, The Wilmer Ophthalmological Institute and Department of Ophthalmology, The Johns Hopkins University School of Medicine and The Johns Hopkins Hospital, Baltimore, Md (Drs S. Bressler, Pieramici, and N. Bressler); and Novartis AG, Duluth, Ga (Mr Koester). Funding for the study described herein was provided by Novartis AG and QLT Inc, Vancouver, British Columbia. The Johns Hopkins University is paid for consulting services provided by Dr N. Bressler to Novartis AG and QLT Inc. The terms of this institutional consulting arrangement are being managed by The Johns Hopkins University in accord with its conflict of interest policies. A complete list of the participants in the TAP Study Group is available in Arch Ophthalmol. 1999;117:1329-1345. Revisions to this list, as of January 11, 2000, are available in Arch Ophthalmol. 2001;119:198-207.

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