Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Collaborating Sponsors:
QLT Inc.
Conditions:
Macular Degeneration
Choroidal Neovascularization
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 triamcinolo...
Eligibility Criteria
Inclusion
- age \>50
- all types of untreated subfoveal choroidal neovascularization secondary to AMD
- lesion size \<5400 microns in greater linear dimension (GLD)
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00242580
Start Date
September 1 2005
Last Update
March 31 2016
Active Locations (1)
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1
Novartis Investigational Site
Austin, Texas, United States, 78793