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
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Degeneration; Choroidal Neovascularization
Intervention: Verteporfin photodynamic therapy (Drug); Pegaptanib (Drug); Triamcinolone acetonide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Novartis Pharmaceuticals Official(s) and/or principal investigator(s): Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
Secondary outcome: Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12 Number of Participants Requiring Verteporfin Treatment Throughout the Study Mean Change From Baseline in Total Area of Lesion at 12 Months
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Novartis Investigational Site, Austin, Texas 78793, United States
Additional Information
Novartis patient recruitment website: Clinical trial information for patients and caregivers
Starting date: September 2005
Last updated: April 1, 2011
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