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H StrongTAP and VIP Study Groups; Predictive Value of Lesion Size on Vision Benefits from Verteporfin Therapy: Exploratory Analyses of Results from the TAP Investigation and VIP Trial . Invest. Ophthalmol. Vis. Sci. 2002;43(13):980.
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Purpose: Results from three clinical trials of verteporfin (Visudyne®, Novartis AG) therapy in CNV secondary to age-related macular degeneration (AMD) have demonstrated that predominantly classic (area of classic CNV is ≥50%) and occult with no classic lesions, but not minimally classic lesions (area of classic CNV is 0%) show visual acuity benefits with verteporfin therapy. The purpose of this investigation is to determine how lesion size may be predictive of better vision outcomes within different lesion compositions. Methods: Exploratory analyses were conducted in patients with predominantly classic or minimally classic lesions enrolled in the Treatment of AMD with Photodynamic therapy (TAP) Investigation (two trials) and AMD patients with occult with no classic CNV in the Verteporfin In Photodynamic therapy (VIP) Trial. Distributions of lesion size among these three lesion compositions were compared. In addition, analysis of covariance (ANCOVA) was used to explore the effect of baseline lesion size, visual acuity, and lesion composition on the change in visual acuity from baseline. Results: The mean size of predominantly classic lesions (3.4 MPS disc areas [DA]) was smaller than for minimally classic (4.7 MPS DA) and occult with no classic lesions (4.3 MPS DA). In addition, the proportion of smaller lesions (≤4 MPS DA) was significantly greater in patients with predominantly classic (65%) than in minimally classic (39%) or occult with no classic (47%) lesions. In the ANCOVA of individual lesion types, there was a significant treatment-by-lesion-size interaction for minimally classic and occult with no classic lesions, but not for predominantly classic lesions. Interactions between treatment and baseline visual acuity were not significant. In the ANCOVA that included all lesion types, lesion size rather than lesion type or visual acuity was the most significant predictive factor for the magnitude of treatment benefit. Smaller (≤4 MPS DA) minimally classic and occult with no classic lesion types had similar benefits (approximately 2 lines relative to placebo) to those observed in predominantly classic lesions. Conclusion: Based on exploratory analyses, lesion size in the TAP Investigation and VIP Trial was an important predictor of the magnitude of treatment benefit with verteporfin therapy in occult with no classic and minimally classic lesion types.
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