VERITAS: 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
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Subfoveal,; Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)
Intervention: intravenous verteporfin, plus intravitreal (intraocular) injection of drug of either triamcinolone acetonide or pegaptanib sodium (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharma, Study Chair, Affiliation: Novartis Customer Information
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 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
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Loss of visual acuity scroe less than 15 lettres from baseline at month 12
Secondary outcome: Gain of viusal acuity score equal or more than 5,10,and 15 lettres from baseline at months 6, 12 and 24Loss of visual acuity score less than 15 lettres from baseline at month 6 and 24 Requirement of verteporfin treatments throughout the study after baseline Changes in best-corrected visual acuity at months 3, 6 and 12 Changes in total size of lesions at month 3,6 and 12
Detailed description:
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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
- recent eye surgery (within the last 2 months)
Other protocol-specified inclusion/exclusion criteria may apply.
Locations and Contacts
Novartis Customer Information, East Hanover, New Jersey, United States
Additional Information
Novartis patient recruitment website: Clinical trial information for patients and caregivers
Starting date: September 2005
Last updated: August 6, 2007
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