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
Completed · Phase 3
Conditions studied: Macular Degeneration, Choroidal Neovascularization
In brief
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.
Key facts
- Study ID
- NCT00242580
- Run by
- Novartis Pharmaceuticals
- People needed
- 111
- Starts
- 2005-09-01
- Last updated by the study team
- 2016-03-31
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age >50
- all types of untreated subfoveal choroidal neovascularization secondary to AMD
- lesion size <5400 microns in greater linear dimension (GLD)
You may not qualify if…
- 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.
Where it is running
- Novartis Investigational Site — Austin, Texas, United States
Full record on ClinicalTrials.gov
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