- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00242580
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 (VERITAS)
March 3, 2016 updated by: Novartis Pharmaceuticals
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
111
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Austin, Texas, United States, 78793
- Novartis Investigational site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
Other Names:
Triamcinolone acetonide administered by intravitreal injection.
Other Names:
|
Experimental: 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.
|
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.
Other Names:
Triamcinolone acetonide administered by intravitreal injection.
Other Names:
|
Active Comparator: 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.
|
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.
Other Names:
Pegaptanib sodium 0.3 mg administered by intravitreal injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
Time Frame: 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.
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.
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Baseline to Month 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12
Time Frame: 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.
|
Baseline to Month 12
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Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months
Time Frame: 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 10 or more letters of visual acuity at 12 months as compared with baseline.
|
Baseline to Month 12
|
Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12
Time Frame: 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 15 or more letters of visual acuity at 12 months as compared with baseline.
|
Baseline to Month 12
|
Number of Participants Requiring Verteporfin Treatment Throughout the Study
Time Frame: Baseline to Month 12
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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.
|
Baseline to Month 12
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Mean Change From Baseline in Total Area of Lesion at 12 Months
Time Frame: Baseline to Month 12
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Fluorescein angiography (FA) was used to assess total lesion area.
All angiographs were sent to the Central Reading Center (CRC) for analysis.
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Baseline to Month 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
January 1, 2008
Study Registration Dates
First Submitted
October 19, 2005
First Submitted That Met QC Criteria
October 19, 2005
First Posted (Estimate)
October 20, 2005
Study Record Updates
Last Update Posted (Estimate)
March 31, 2016
Last Update Submitted That Met QC Criteria
March 3, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Uveal Diseases
- Choroid Diseases
- Metaplasia
- Macular Degeneration
- Choroidal Neovascularization
- Neovascularization, Pathologic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Photosensitizing Agents
- Dermatologic Agents
- Verteporfin
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- CBPD952E2202
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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