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W.F. Mieler, The VERITAS Trial; VERITAS – The Rationale and Design of a Combination Therapy Trial For Wet AMD . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5232.
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Verteporfin photodynamic therapy (PDT) reduces the risk of moderate and severe visual acuity (VA) loss. There is evidence to suggest that the treatment effect may be improved by adjunctive treatment with other pharmacologic agents. VERITAS, a clinical trial designed to evaluate the safety and efficacy of a steroid or an anti–VEGF agent when combined with verteporfin PDT, has recently been started in patients with subfoveal CNV secondary to AMD. The objectives of the trial are to compare the VA outcomes, anatomic outcomes and safety in patients treated with either combination therapy.
VERITAS is a 24–month, randomized, sham–controlled, double–masked study which will enroll approximately 340 patients at 50 centers in the USA. A reading center will retrospectively evaluate the fluorescein angiographic (FA) and photographic characteristics of the lesions as well as OCT3 images. Participants will be randomly assigned (1:1:1) to one of the combination therapy arms of verteporfin PDT with either two different doses of a steroid or an anti–VEGF. All patients will receive verteporfin PDT followed by the intravitreal injection of the adjunctive agent on the same day. In the first year all study arms will receive scheduled treatments for follow up. During the second year, patients will be treated at the Investigators’ discretion. Inclusion criteria are: age ≥50 years, study eye BCVA letter score ETDRS of 73–24 (approximately Snellen 20/40 to 20/320), subfoveal CNV lesion of any type, with CNV area ≥50% of total lesion and a GLD ≤5400 microns. In addition, presumed recent disease progression must be observed in occult with no classic CNV lesions. Main exclusion criteria include any prior treatment for CNV in the study eye and CNV secondary to other causes than AMD.
The rationale for combination therapy and the study design will be presented.
The results from this randomized trial will provide clinicians further insight into the utility of combination therapy with verteporfin PDT with respect to efficacy, safety and treatment course.
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