A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One … (NCT00242580) | Clinical Trial Compass
CompletedPhase 3
A Safety and Efficacy Study Comparing the Combination Treatments of Verteporfin Therapy Plus One of Two Different Doses of Intravitreal Triamcinolone Acetonide and the Verteporfin Therapy Plus Intravitreal Pegaptanib
United States111 participantsStarted 2005-09
Plain-language summary
To evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration. The combination treatment consists of verteporfin photodynamic therapy and either triamcinolone acetonide or pegaptanib added as an intravitreal injection.
Who can participate
Age range50 Years
SexALL
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Inclusion Criteria:
* age \>50
* all types of untreated subfoveal choroidal neovascularization secondary to AMD
* lesion size \<5400 microns in greater linear dimension (GLD)
Exclusion Criteria:
* have a history of prior photodynamic therapy, external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
* known allergy to verteporfin, triamcinolone or pegaptanib
* have received prior treatment with Macugen, or other anti-angiogenic compound or any investigational treatment (e.g. Ruboxistaurin, Lucentis \[ranibizumab\], Retaane \[anecortave acetate\], squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD
* have the presence of fibrosis, hemorrhage, pigment epithelial detachments, tear (tip) of the retinal pigment epithelium or other hypoflourescent lesions obscuring greater than 50% of the CNV lesion
* have had previous pars plana vitrectomy in the study eye
Other protocol-specified inclusion/exclusion criteria applied.
What they're measuring
1
Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.