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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
Sponsor:
Collaborator:
QLT Inc.
Information provided by:
Novartis

Study Type Interventional
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
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
Hide Arm/Group 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.
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.
Arm/Group Title Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 32 41 38 111
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 32 participants 41 participants 38 participants 111 participants
Female
18
  56.3%
25
  61.0%
20
  52.6%
63
  56.8%
Male
14
  43.8%
16
  39.0%
18
  47.4%
48
  43.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 41 participants 38 participants 111 participants
32 41 38 111
1.Primary Outcome
Title Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.
Arm/Group Title Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib
Hide Arm/Group 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.
Overall Number of Participants Analyzed 32 41 38
Measure Type: Number
Unit of Measure: Percentage of Participants
59.4 63.4 71.1
2.Secondary Outcome
Title Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.
Arm/Group Title Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib
Hide Arm/Group 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.
Overall Number of Participants Analyzed 32 41 38
Measure Type: Number
Unit of Measure: Percentage of Participants
31.3 12.2 28.9
3.Secondary Outcome
Title Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.
Arm/Group Title Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib
Hide Arm/Group 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.
Overall Number of Participants Analyzed 32 41 38
Measure Type: Number
Unit of Measure: Percentage of Participants
18.8 2.4 23.7
4.Secondary Outcome
Title Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy variable analyses were performed on the intent-to-treat (ITT) data set. The ITT set includes data from all randomized patients. Missing data were imputed using last observation carried forward.
Arm/Group Title Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib
Hide Arm/Group 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.
Overall Number of Participants Analyzed 32 41 38
Measure Type: Number
Unit of Measure: Percentage of Participants
6.3 0 13.2
5.Secondary Outcome
Title Number of Participants Requiring Verteporfin Treatment Throughout the Study
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Observed data.
Arm/Group Title Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib
Hide Arm/Group 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.
Overall Number of Participants Analyzed 32 41 38
Measure Type: Number
Unit of Measure: Participants
Participants who received 1 treatment 11 12 10
Participants who received 2 treatments 10 15 19
Participants who received 3 treatments 9 12 5
Participants who received 4 treatments 2 2 4
6.Secondary Outcome
Title Mean Change From Baseline in Total Area of Lesion at 12 Months
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.
Arm/Group Title Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib
Hide Arm/Group 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.
Overall Number of Participants Analyzed 32 41 38
Mean (Standard Deviation)
Unit of Measure: mm^2
Baseline 6.9178  (5.9455) 5.6400  (3.7154) 6.3011  (5.4794)
12 Months 6.8959  (7.6848) 5.8149  (4.6465) 8.6245  (7.1242)
Change from Baseline -0.0219  (7.7026) 0.1749  (4.2357) 2.3234  (5.9370)
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib
Hide Arm/Group 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.
All-Cause Mortality
Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/32 (34.38%)   9/41 (21.95%)   10/38 (26.32%) 
Cardiac disorders       
ARRHYTHMIA  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
ATRIAL FIBRILLATION  1  0/32 (0.00%)  1/41 (2.44%)  0/38 (0.00%) 
CONGESTIVE HEART FAILURE  1  1/32 (3.13%)  0/41 (0.00%)  0/38 (0.00%) 
CORONARY ARTERY DISORDER  1  0/32 (0.00%)  2/41 (4.88%)  1/38 (2.63%) 
HEART BLOCK  1  1/32 (3.13%)  0/41 (0.00%)  0/38 (0.00%) 
MYOCARDIAL INFARCT  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
Ear and labyrinth disorders       
VERTIGO  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
Gastrointestinal disorders       
CONSTIPATION  1  0/32 (0.00%)  1/41 (2.44%)  0/38 (0.00%) 
GASTRITIS  1  0/32 (0.00%)  1/41 (2.44%)  0/38 (0.00%) 
GASTROINTESTINAL DISORDER  1  1/32 (3.13%)  0/41 (0.00%)  2/38 (5.26%) 
GASTROINTESTINAL HEMORRHAGE  1  0/32 (0.00%)  1/41 (2.44%)  0/38 (0.00%) 
PANCREATITIS  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
PEPTIC ULCER HEMORRHAGE  1  0/32 (0.00%)  1/41 (2.44%)  0/38 (0.00%) 
General disorders       
CHEST PAIN  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
CYST  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
HERNIA  1  0/32 (0.00%)  1/41 (2.44%)  0/38 (0.00%) 
Hepatobiliary disorders       
CHOLECYSTITIS  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
CHOLELITHIASIS  1  0/32 (0.00%)  1/41 (2.44%)  1/38 (2.63%) 
Immune system disorders       
ANAPHYLACTOID REACTION  1  1/32 (3.13%)  0/41 (0.00%)  0/38 (0.00%) 
Infections and infestations       
INFECTION  1  1/32 (3.13%)  0/41 (0.00%)  0/38 (0.00%) 
PNEUMONIA  1  1/32 (3.13%)  2/41 (4.88%)  2/38 (5.26%) 
Injury, poisoning and procedural complications       
ACCIDENTAL INJURY  1  2/32 (6.25%)  1/41 (2.44%)  3/38 (7.89%) 
Metabolism and nutrition disorders       
HYPOKALEMIA  1  1/32 (3.13%)  0/41 (0.00%)  0/38 (0.00%) 
Musculoskeletal and connective tissue disorders       
OSTEOPOROSIS  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
NEOPLASM  1  1/32 (3.13%)  0/41 (0.00%)  0/38 (0.00%) 
Nervous system disorders       
CEREBRAL INFARCT  1  0/32 (0.00%)  2/41 (4.88%)  0/38 (0.00%) 
CEREBRAL ISCHEMIA  1  1/32 (3.13%)  0/41 (0.00%)  1/38 (2.63%) 
CEREBROVASCULAR ACCIDENT  1  0/32 (0.00%)  1/41 (2.44%)  0/38 (0.00%) 
ENCEPHALOPATHY  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
Renal and urinary disorders       
ACUTE KIDNEY FAILURE  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
Respiratory, thoracic and mediastinal disorders       
LUNG EDEMA  1  0/32 (0.00%)  1/41 (2.44%)  0/38 (0.00%) 
Vascular disorders       
AORTIC STENOSIS  1  0/32 (0.00%)  1/41 (2.44%)  0/38 (0.00%) 
ARTERIAL ANOMALY  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
ARTERIAL THROMBOSIS  1  1/32 (3.13%)  0/41 (0.00%)  0/38 (0.00%) 
ARTERIOSCLEROSIS  1  1/32 (3.13%)  0/41 (0.00%)  0/38 (0.00%) 
DEEP THROMBOPHLEBITIS  1  0/32 (0.00%)  0/41 (0.00%)  1/38 (2.63%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Verteporfin + 1 mg Triamcinolone Verteporfin + 4 mg Triamcinolone Verteporfin + Pegaptanib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   32/32 (100.00%)   38/41 (92.68%)   30/38 (78.95%) 
Blood and lymphatic system disorders       
ANEMIA  1  0/32 (0.00%)  3/41 (7.32%)  1/38 (2.63%) 
Cardiac disorders       
CORONARY ARTERY DISORDER  1  0/32 (0.00%)  3/41 (7.32%)  1/38 (2.63%) 
Ear and labyrinth disorders       
TINNITUS  1  0/32 (0.00%)  0/41 (0.00%)  2/38 (5.26%) 
Eye disorders       
AMD PROGRESSION (Fellow eye)  1  5/32 (15.63%)  6/41 (14.63%)  7/38 (18.42%) 
BLEPHARITIS (Fellow eye)  1  0/32 (0.00%)  0/41 (0.00%)  2/38 (5.26%) 
CATARACT (Fellow eye)  1  3/32 (9.38%)  4/41 (9.76%)  2/38 (5.26%) 
CONJUNCTIVITIS (Fellow eye)  1  2/32 (6.25%)  0/41 (0.00%)  2/38 (5.26%) 
DRY EYES (Fellow eye)  1  1/32 (3.13%)  1/41 (2.44%)  4/38 (10.53%) 
EYE DISORDER (Fellow eye)  1  0/32 (0.00%)  1/41 (2.44%)  2/38 (5.26%) 
EYE ITCHING (Fellow eye)  1  2/32 (6.25%)  0/41 (0.00%)  0/38 (0.00%) 
RETINAL DISORDER (Fellow eye)  1  2/32 (6.25%)  3/41 (7.32%)  2/38 (5.26%) 
RETINAL HEMORRHAGE (Fellow eye)  1  1/32 (3.13%)  0/41 (0.00%)  2/38 (5.26%) 
SUBRETINAL HEMORRHAGE (Fellow eye)  1  2/32 (6.25%)  0/41 (0.00%)  0/38 (0.00%) 
VISION DECREASED (Fellow eye)  1  0/32 (0.00%)  1/41 (2.44%)  2/38 (5.26%) 
ACUTE ELEVATED IOP (Study eye)  1  2/32 (6.25%)  7/41 (17.07%)  0/38 (0.00%) 
AMD PROGRESSION (Study eye)  1  6/32 (18.75%)  8/41 (19.51%)  3/38 (7.89%) 
BLEPHARITIS (Study eye)  1  1/32 (3.13%)  0/41 (0.00%)  2/38 (5.26%) 
CATARACT (Study eye)  1  8/32 (25.00%)  10/41 (24.39%)  2/38 (5.26%) 
CONJUNCTIVITIS (Study eye)  1  3/32 (9.38%)  0/41 (0.00%)  2/38 (5.26%) 
DRY EYES (Study eye)  1  1/32 (3.13%)  2/41 (4.88%)  4/38 (10.53%) 
EYE HEMORRHAGE (Study eye)  1  5/32 (15.63%)  7/41 (17.07%)  7/38 (18.42%) 
EYE ITCHING (Study eye)  1  2/32 (6.25%)  0/41 (0.00%)  0/38 (0.00%) 
EYE PAIN (Study eye)  1  2/32 (6.25%)  5/41 (12.20%)  2/38 (5.26%) 
RETINAL DISORDER (Study eye)  1  1/32 (3.13%)  3/41 (7.32%)  1/38 (2.63%) 
RETINAL EDEMA (Study eye)  1  3/32 (9.38%)  4/41 (9.76%)  0/38 (0.00%) 
RETINAL HEMORRHAGE (Study eye)  1  2/32 (6.25%)  2/41 (4.88%)  0/38 (0.00%) 
RETINAL PIGMENTATION (Study eye)  1  1/32 (3.13%)  1/41 (2.44%)  2/38 (5.26%) 
SUBRETINAL HEMORRHAGE (Study eye)  1  3/32 (9.38%)  1/41 (2.44%)  2/38 (5.26%) 
VISION ABNORMAL (Study eye)  1  4/32 (12.50%)  5/41 (12.20%)  3/38 (7.89%) 
VISION DECREASED (Study eye)  1  1/32 (3.13%)  3/41 (7.32%)  3/38 (7.89%) 
Gastrointestinal disorders       
DIARRHEA  1  1/32 (3.13%)  2/41 (4.88%)  2/38 (5.26%) 
DYSPEPSIA  1  2/32 (6.25%)  2/41 (4.88%)  1/38 (2.63%) 
GASTROINTESTINAL DISORDER  1  1/32 (3.13%)  4/41 (9.76%)  3/38 (7.89%) 
NAUSEA  1  4/32 (12.50%)  0/41 (0.00%)  3/38 (7.89%) 
RECTAL DISORDER  1  0/32 (0.00%)  3/41 (7.32%)  0/38 (0.00%) 
General disorders       
PAIN  1  5/32 (15.63%)  4/41 (9.76%)  3/38 (7.89%) 
PERIPHERAL EDEMA  1  2/32 (6.25%)  0/41 (0.00%)  2/38 (5.26%) 
Infections and infestations       
INFECTION  1  5/32 (15.63%)  2/41 (4.88%)  0/38 (0.00%) 
BRONCHITIS  1  2/32 (6.25%)  0/41 (0.00%)  1/38 (2.63%) 
PNEUMONIA  1  0/32 (0.00%)  1/41 (2.44%)  2/38 (5.26%) 
RHINITIS  1  3/32 (9.38%)  6/41 (14.63%)  2/38 (5.26%) 
SINUSITIS  1  2/32 (6.25%)  2/41 (4.88%)  1/38 (2.63%) 
Injury, poisoning and procedural complications       
ACCIDENTAL INJURY  1  0/32 (0.00%)  2/41 (4.88%)  5/38 (13.16%) 
INJECTION SITE EXTRAVASATION  1  2/32 (6.25%)  0/41 (0.00%)  3/38 (7.89%) 
Metabolism and nutrition disorders       
HYPERLIPEMIA  1  2/32 (6.25%)  0/41 (0.00%)  2/38 (5.26%) 
Musculoskeletal and connective tissue disorders       
BACK PAIN  1  2/32 (6.25%)  3/41 (7.32%)  0/38 (0.00%) 
ARTHRITIS  1  1/32 (3.13%)  4/41 (9.76%)  0/38 (0.00%) 
Nervous system disorders       
HEADACHE  1  4/32 (12.50%)  1/41 (2.44%)  3/38 (7.89%) 
Psychiatric disorders       
ANXIETY  1  0/32 (0.00%)  1/41 (2.44%)  2/38 (5.26%) 
DEMENTIA  1  0/32 (0.00%)  2/41 (4.88%)  2/38 (5.26%) 
INSOMNIA  1  0/32 (0.00%)  0/41 (0.00%)  3/38 (7.89%) 
Renal and urinary disorders       
URINARY TRACT INFECTION  1  2/32 (6.25%)  5/41 (12.20%)  5/38 (13.16%) 
Respiratory, thoracic and mediastinal disorders       
COUGH INCREASED  1  0/32 (0.00%)  3/41 (7.32%)  2/38 (5.26%) 
LUNG DISORDER  1  1/32 (3.13%)  0/41 (0.00%)  2/38 (5.26%) 
Skin and subcutaneous tissue disorders       
CONTACT DERMATITIS  1  0/32 (0.00%)  0/41 (0.00%)  2/38 (5.26%) 
PRURITUS  1  0/32 (0.00%)  0/41 (0.00%)  2/38 (5.26%) 
SKIN DISORDER  1  2/32 (6.25%)  0/41 (0.00%)  0/38 (0.00%) 
Vascular disorders       
HYPERTENSION  1  7/32 (21.88%)  7/41 (17.07%)  2/38 (5.26%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
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.
Certain Agreements
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     History of Changes
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