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P. K. Kaiser, VERITAS Study Group; Verteporfin Therapy in Combination With Pegaptanib or Triamcinolone for Wet AMD: 6-Month Results of the VERITAS Trial. Invest. Ophthalmol. Vis. Sci. 2007;48(13):2870.
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Verteporfin photodynamic therapy (PDT) monotherapy reduces the risk of moderate and severe visual acuity (VA) loss. Based on evidence that suggests that the treatment effect may be improved by adjunctive treatment with other pharmacologic agents, VERITAS was designed to evaluate the safety and efficacy of combining a steroid or an anti-VEGF agent with verteporfin PDT.
VERITAS is a prospective randomized, double-masked, multicenter clinical trial to compare the efficacy and safety of verteporfin PDT combined with pegaptanib versus triamcinolone acetonide. Patients with subfoveal choroidal neovascularization (CNV) caused by age-related macular degeneration (AMD) who met the following inclusion criteria were enrolled: age >=50 years; study-eye best-corrected VA letter score of 73 to 24 (Snellen equivalent 20/40 to 20/320); CNV >=50% of the total lesion area; any CNV lesion composition; greatest linear dimension <=5400 microns; and evidence of presumed recent disease progression in those lesions with occult with no classic CNV. Patients (n=111) were randomly assigned (1:1:1) to verteporfin PDT and either intravitreal pegaptanib sodium (0.3 mg) or 1 of 2 doses of intravitreal triamcinolone acetonide (1 mg or 4 mg). The primary endpoint of the trial is the proportion of patients losing <15 letters of VA at month 12.
111 patients were enrolled. Mean age was 78.5 years and mean VA letter score was 53.4 at baseline (approximate Snellen equivalent 20/80-2). Slightly more women were enrolled than men, and 94% of patients were Caucasian. At baseline, 36% of patients presented with classic CNV, 29% with occult with no classic CNV, and the remaining 34% had both classic and occult CNV; 64% of lesions were <=3 DA in size and 32% >3 DA but <=6 DA. Six-month interim analysis data will be presented, including OCT and FA results.
Data from VERITAS will provide clinicians with further insight into the efficacy, safety, and treatment courses when using verteporfin PDT in combination with other agents for the treatment of AMD.
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