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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Page 1 of 1 (1 locations)

1

Novartis Investigational Site

Austin, Texas, United States, 78793