Back to resultsA 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 (VERITAS)
Primary Purpose
Macular Degeneration, Choroidal Neovascularization
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Verteporfin photodynamic therapy
Pegaptanib
Triamcinolone acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, age-related macular degeneration, choroidal neovascularization
Eligibility 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.
Sites / Locations
- Novartis Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Verteporfin and Triamcinolone 1 mg
Verteporfin and Triamcinolone 4 mg
Verteporfin and Pegaptanib
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.
Secondary Outcome Measures
Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.
Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline.
Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline.
Number of Participants Requiring Verteporfin Treatment Throughout the Study
Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm.
Mean Change From Baseline in Total Area of Lesion at 12 Months
Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.
Full Information
NCT ID
NCT00242580
First Posted
October 19, 2005
Last Updated
March 3, 2016
Sponsor
Novartis Pharmaceuticals
Collaborators
QLT Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00242580
Brief 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
Acronym
VERITAS
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 Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
January 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
Collaborators
QLT Inc.
4. Oversight
5. Study Description
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 triamcinolone acetonide or pegaptanib added as an intravitreal injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Choroidal Neovascularization
Keywords
AMD, age-related macular degeneration, choroidal neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Verteporfin and Triamcinolone 1 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Verteporfin and Triamcinolone 4 mg
Arm Type
Experimental
Arm Description
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.
Arm Title
Verteporfin and Pegaptanib
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Verteporfin photodynamic therapy
Other Intervention Name(s)
Visudyne
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pegaptanib
Other Intervention Name(s)
Macugen
Intervention Description
Pegaptanib sodium 0.3 mg administered by intravitreal injection.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide
Other Intervention Name(s)
Kenalog-40®
Intervention Description
Triamcinolone acetonide administered by intravitreal injection.
Primary Outcome Measure Information:
Title
Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
Description
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.
Time Frame
Baseline to Month 12
Secondary Outcome Measure Information:
Title
Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12
Description
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 5 or more letters of visual acuity at 12 months compared with baseline.
Time Frame
Baseline to Month 12
Title
Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months
Description
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 10 or more letters of visual acuity at 12 months as compared with baseline.
Time Frame
Baseline to Month 12
Title
Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12
Description
BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at 12 months as compared with baseline.
Time Frame
Baseline to Month 12
Title
Number of Participants Requiring Verteporfin Treatment Throughout the Study
Description
Participants received study drug at the Baseline visit and subsequent retreatment at 3 month intervals if leakage was detected on the fluorescein angiogram. The cumulative distribution of the number of treatments is shown per arm.
Time Frame
Baseline to Month 12
Title
Mean Change From Baseline in Total Area of Lesion at 12 Months
Description
Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.
Time Frame
Baseline to Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigational Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78793
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.novartisclinicaltrials.com/etrials/DiseaseID83/Age-Related-Macular-Degeneration-clinical-trials.go
Description
Novartis patient recruitment website: Clinical trial information for patients and caregivers
Learn more about this trial
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
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