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
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2005 |
A 24-month Randomized, Double-masked, Sham Controlled, Multicenter, Phase IIIB Study Comparing Photodynamic Therapy With Verteporfin (Visudyne®) Plus Two Different Dose Regimens of Intravitreal Triamcinolone Acetonide (1 mg and 4 mg) Versus Visudyne® Plus Intravitreal Pegaptanib(Macugen®) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
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.
degeneration. The combination treatment consists of verteporfin photodynamic therapy and
either triamcinolone acetonide or pegaptanib added as an intravitreal injection.
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.
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