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
NCT ID: NCT00242580
Last Updated: 2016-03-31
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
111 participants
INTERVENTIONAL
2005-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Verteporfin and Triamcinolone 1 mg
Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
Verteporfin photodynamic therapy
After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.
Triamcinolone acetonide
Triamcinolone acetonide administered by intravitreal injection.
Verteporfin and Triamcinolone 4 mg
Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
Verteporfin photodynamic therapy
After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.
Triamcinolone acetonide
Triamcinolone acetonide administered by intravitreal injection.
Verteporfin and Pegaptanib
Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
Verteporfin photodynamic therapy
After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.
Pegaptanib
Pegaptanib sodium 0.3 mg administered by intravitreal injection.
Interventions
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Verteporfin photodynamic therapy
After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion.
Pegaptanib
Pegaptanib sodium 0.3 mg administered by intravitreal injection.
Triamcinolone acetonide
Triamcinolone acetonide administered by intravitreal injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* all types of untreated subfoveal choroidal neovascularization secondary to AMD
* lesion size \<5400 microns in greater linear dimension (GLD)
Exclusion Criteria
* 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
50 Years
ALL
No
Sponsors
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QLT Inc.
INDUSTRY
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Novartis Investigational Site
Austin, Texas, United States
Countries
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Related Links
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Novartis patient recruitment website: Clinical trial information for patients and caregivers
Other Identifiers
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CBPD952E2202
Identifier Type: -
Identifier Source: org_study_id
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