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)
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ClinicalTrials.gov Identifier: NCT00242580 |
Recruitment Status :
Completed
First Posted : October 20, 2005
Results First Posted : May 2, 2011
Last Update Posted : March 31, 2016
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Sponsor:
Novartis Pharmaceuticals
Collaborator:
QLT Inc.
Information provided by:
Novartis
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Macular Degeneration Choroidal Neovascularization |
Interventions |
Drug: Verteporfin photodynamic therapy Drug: Pegaptanib Drug: Triamcinolone acetonide |
Enrollment | 111 |
Participant Flow
Recruitment Details | The protocol was amended to limit the sample size from 339 to 100. 111 entered the study and and were part of the 12 mo analysis. The study was subsequently terminated. The patients did not receive study drug during the second year of the study. |
Pre-assignment Details |
Arm/Group Title | Verteporfin + 1 mg Triamcinolone | Verteporfin + 4 mg Triamcinolone | Verteporfin + Pegaptanib |
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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. |
Period Title: Overall Study | |||
Started | 32 | 41 | 38 |
Completed | 22 [1] | 29 | 24 |
Not Completed | 10 | 12 | 14 |
Reason Not Completed | |||
Adverse Event | 3 | 0 | 2 |
Unsatisfactory therapeutic effect | 4 | 5 | 5 |
Protocol Violation | 0 | 0 | 1 |
Subject withdrew consent | 2 | 2 | 5 |
Lost to Follow-up | 0 | 3 | 0 |
Death | 1 | 2 | 1 |
[1]
"Completed" indicates 12 month data.
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Baseline Characteristics
Arm/Group Title | Verteporfin + 1 mg Triamcinolone | Verteporfin + 4 mg Triamcinolone | Verteporfin + Pegaptanib | Total | |
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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. | Total of all reporting groups | |
Overall Number of Baseline Participants | 32 | 41 | 38 | 111 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 32 participants | 41 participants | 38 participants | 111 participants | |
76 (9) | 78 (8) | 81 (6) | 78 (8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 32 participants | 41 participants | 38 participants | 111 participants | |
Female |
18 56.3%
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25 61.0%
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20 52.6%
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63 56.8%
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Male |
14 43.8%
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16 39.0%
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18 47.4%
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48 43.2%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 32 participants | 41 participants | 38 participants | 111 participants |
32 | 41 | 38 | 111 |
Outcome Measures
Adverse Events
Limitations and Caveats
Secondary outcome measures were to be assessed at Month 6 and at 24 months. However, this study was not completed but terminated after all patients completed 12 months. Original safety was COSTART now mapped to SOC MedDRA.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: | Study Director |
Organization: | Novartis Pharmaceuticals |
Phone: | 862 778-8300 |
Responsible Party: | External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00242580 |
Other Study ID Numbers: |
CBPD952E2202 |
First Submitted: | October 19, 2005 |
First Posted: | October 20, 2005 |
Results First Submitted: | January 24, 2011 |
Results First Posted: | May 2, 2011 |
Last Update Posted: | March 31, 2016 |