Trial Outcomes & Findings for 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 NCT00242580)
NCT ID: NCT00242580
Last Updated: 2016-03-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
111 participants
Primary outcome timeframe
Baseline to Month 12
Results posted on
2016-03-31
Participant Flow
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.
Participant milestones
| Measure |
Verteporfin + 1 mg Triamcinolone
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 + 4 mg Triamcinolone
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 + 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
32
|
41
|
38
|
|
Overall Study
COMPLETED
|
22
|
29
|
24
|
|
Overall Study
NOT COMPLETED
|
10
|
12
|
14
|
Reasons for withdrawal
| Measure |
Verteporfin + 1 mg Triamcinolone
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 + 4 mg Triamcinolone
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 + 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.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
0
|
2
|
|
Overall Study
Unsatisfactory therapeutic effect
|
4
|
5
|
5
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
|
Overall Study
Subject withdrew consent
|
2
|
2
|
5
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
|
Overall Study
Death
|
1
|
2
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Verteporfin + 1 mg Triamcinolone
n=32 Participants
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 + 4 mg Triamcinolone
n=41 Participants
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 + Pegaptanib
n=38 Participants
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
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
76 years
STANDARD_DEVIATION 9 • n=5 Participants
|
78 years
STANDARD_DEVIATION 8 • n=7 Participants
|
81 years
STANDARD_DEVIATION 6 • n=5 Participants
|
78 years
STANDARD_DEVIATION 8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=5 Participants
|
41 participants
n=7 Participants
|
38 participants
n=5 Participants
|
111 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.
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.
Outcome measures
| Measure |
Verteporfin + 1 mg Triamcinolone
n=32 Participants
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 + 4 mg Triamcinolone
n=41 Participants
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 + Pegaptanib
n=38 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
|
59.4 Percentage of Participants
|
63.4 Percentage of Participants
|
71.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.
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.
Outcome measures
| Measure |
Verteporfin + 1 mg Triamcinolone
n=32 Participants
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 + 4 mg Triamcinolone
n=41 Participants
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 + Pegaptanib
n=38 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12
|
31.3 Percentage of Participants
|
12.2 Percentage of Participants
|
28.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.
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.
Outcome measures
| Measure |
Verteporfin + 1 mg Triamcinolone
n=32 Participants
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 + 4 mg Triamcinolone
n=41 Participants
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 + Pegaptanib
n=38 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months
|
18.8 Percentage of Participants
|
2.4 Percentage of Participants
|
23.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: 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.
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.
Outcome measures
| Measure |
Verteporfin + 1 mg Triamcinolone
n=32 Participants
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 + 4 mg Triamcinolone
n=41 Participants
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 + Pegaptanib
n=38 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12
|
6.3 Percentage of Participants
|
0 Percentage of Participants
|
13.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Observed data.
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.
Outcome measures
| Measure |
Verteporfin + 1 mg Triamcinolone
n=32 Participants
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 + 4 mg Triamcinolone
n=41 Participants
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 + Pegaptanib
n=38 Participants
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.
|
|---|---|---|---|
|
Number of Participants Requiring Verteporfin Treatment Throughout the Study
Participants who received 1 treatment
|
11 Participants
0
|
12 Participants
0
|
10 Participants
0
|
|
Number of Participants Requiring Verteporfin Treatment Throughout the Study
Participants who received 2 treatments
|
10 Participants
|
15 Participants
|
19 Participants
|
|
Number of Participants Requiring Verteporfin Treatment Throughout the Study
Participants who received 3 treatments
|
9 Participants
|
12 Participants
|
5 Participants
|
|
Number of Participants Requiring Verteporfin Treatment Throughout the Study
Participants who received 4 treatments
|
2 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline to Month 12Population: Intent-to-treat (ITT) data set includes data from all randomized patients. Missing data were imputed using last observation carried forward.
Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.
Outcome measures
| Measure |
Verteporfin + 1 mg Triamcinolone
n=32 Participants
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 + 4 mg Triamcinolone
n=41 Participants
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 + Pegaptanib
n=38 Participants
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.
|
|---|---|---|---|
|
Mean Change From Baseline in Total Area of Lesion at 12 Months
Baseline
|
6.9178 mm^2
Standard Deviation 5.9455
|
5.6400 mm^2
Standard Deviation 3.7154
|
6.3011 mm^2
Standard Deviation 5.4794
|
|
Mean Change From Baseline in Total Area of Lesion at 12 Months
12 Months
|
6.8959 mm^2
Standard Deviation 7.6848
|
5.8149 mm^2
Standard Deviation 4.6465
|
8.6245 mm^2
Standard Deviation 7.1242
|
|
Mean Change From Baseline in Total Area of Lesion at 12 Months
Change from Baseline
|
-0.0219 mm^2
Standard Deviation 7.7026
|
0.1749 mm^2
Standard Deviation 4.2357
|
2.3234 mm^2
Standard Deviation 5.9370
|
Adverse Events
Verteporfin + 1 mg Triamcinolone
Serious events: 11 serious events
Other events: 32 other events
Deaths: 0 deaths
Verteporfin + 4 mg Triamcinolone
Serious events: 9 serious events
Other events: 38 other events
Deaths: 0 deaths
Verteporfin + Pegaptanib
Serious events: 10 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Verteporfin + 1 mg Triamcinolone
n=32 participants at risk
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 + 4 mg Triamcinolone
n=41 participants at risk
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 + Pegaptanib
n=38 participants at risk
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.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
ACCIDENTAL INJURY
|
6.2%
2/32 • 12 months
|
2.4%
1/41 • 12 months
|
7.9%
3/38 • 12 months
|
|
Immune system disorders
ANAPHYLACTOID REACTION
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
General disorders
CHEST PAIN
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
General disorders
CYST
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
General disorders
HERNIA
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Infections and infestations
INFECTION
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Vascular disorders
AORTIC STENOSIS
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Vascular disorders
ARTERIAL ANOMALY
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Vascular disorders
ARTERIAL THROMBOSIS
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Cardiac disorders
CONGESTIVE HEART FAILURE
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Cardiac disorders
CORONARY ARTERY DISORDER
|
0.00%
0/32 • 12 months
|
4.9%
2/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Vascular disorders
DEEP THROMBOPHLEBITIS
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Cardiac disorders
HEART BLOCK
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Cardiac disorders
MYOCARDIAL INFARCT
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL HEMORRHAGE
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Gastrointestinal disorders
PEPTIC ULCER HEMORRHAGE
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Nervous system disorders
CEREBRAL INFARCT
|
0.00%
0/32 • 12 months
|
4.9%
2/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Nervous system disorders
CEREBRAL ISCHEMIA
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
LUNG EDEMA
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Infections and infestations
PNEUMONIA
|
3.1%
1/32 • 12 months
|
4.9%
2/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Renal and urinary disorders
ACUTE KIDNEY FAILURE
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
Other adverse events
| Measure |
Verteporfin + 1 mg Triamcinolone
n=32 participants at risk
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 + 4 mg Triamcinolone
n=41 participants at risk
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 + Pegaptanib
n=38 participants at risk
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.
|
|---|---|---|---|
|
Eye disorders
EYE ITCHING (Study eye)
|
6.2%
2/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Eye disorders
EYE PAIN (Study eye)
|
6.2%
2/32 • 12 months
|
12.2%
5/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
RETINAL DISORDER (Study eye)
|
3.1%
1/32 • 12 months
|
7.3%
3/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Eye disorders
RETINAL EDEMA (Study eye)
|
9.4%
3/32 • 12 months
|
9.8%
4/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Eye disorders
RETINAL HEMORRHAGE (Study eye)
|
6.2%
2/32 • 12 months
|
4.9%
2/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Eye disorders
RETINAL PIGMENTATION (Study eye)
|
3.1%
1/32 • 12 months
|
2.4%
1/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
SUBRETINAL HEMORRHAGE (Study eye)
|
9.4%
3/32 • 12 months
|
2.4%
1/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
VISION ABNORMAL (Study eye)
|
12.5%
4/32 • 12 months
|
12.2%
5/41 • 12 months
|
7.9%
3/38 • 12 months
|
|
Eye disorders
VISION DECREASED (Study eye)
|
3.1%
1/32 • 12 months
|
7.3%
3/41 • 12 months
|
7.9%
3/38 • 12 months
|
|
Renal and urinary disorders
URINARY TRACT INFECTION
|
6.2%
2/32 • 12 months
|
12.2%
5/41 • 12 months
|
13.2%
5/38 • 12 months
|
|
Injury, poisoning and procedural complications
ACCIDENTAL INJURY
|
0.00%
0/32 • 12 months
|
4.9%
2/41 • 12 months
|
13.2%
5/38 • 12 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
6.2%
2/32 • 12 months
|
7.3%
3/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Nervous system disorders
HEADACHE
|
12.5%
4/32 • 12 months
|
2.4%
1/41 • 12 months
|
7.9%
3/38 • 12 months
|
|
Infections and infestations
INFECTION
|
15.6%
5/32 • 12 months
|
4.9%
2/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Injury, poisoning and procedural complications
INJECTION SITE EXTRAVASATION
|
6.2%
2/32 • 12 months
|
0.00%
0/41 • 12 months
|
7.9%
3/38 • 12 months
|
|
General disorders
PAIN
|
15.6%
5/32 • 12 months
|
9.8%
4/41 • 12 months
|
7.9%
3/38 • 12 months
|
|
Cardiac disorders
CORONARY ARTERY DISORDER
|
0.00%
0/32 • 12 months
|
7.3%
3/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Vascular disorders
HYPERTENSION
|
21.9%
7/32 • 12 months
|
17.1%
7/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Gastrointestinal disorders
DIARRHEA
|
3.1%
1/32 • 12 months
|
4.9%
2/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.2%
2/32 • 12 months
|
4.9%
2/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
3.1%
1/32 • 12 months
|
9.8%
4/41 • 12 months
|
7.9%
3/38 • 12 months
|
|
Gastrointestinal disorders
NAUSEA
|
12.5%
4/32 • 12 months
|
0.00%
0/41 • 12 months
|
7.9%
3/38 • 12 months
|
|
Gastrointestinal disorders
RECTAL DISORDER
|
0.00%
0/32 • 12 months
|
7.3%
3/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.00%
0/32 • 12 months
|
7.3%
3/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Metabolism and nutrition disorders
HYPERLIPEMIA
|
6.2%
2/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
General disorders
PERIPHERAL EDEMA
|
6.2%
2/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
3.1%
1/32 • 12 months
|
9.8%
4/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Psychiatric disorders
DEMENTIA
|
0.00%
0/32 • 12 months
|
4.9%
2/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
7.9%
3/38 • 12 months
|
|
Infections and infestations
BRONCHITIS
|
6.2%
2/32 • 12 months
|
0.00%
0/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH INCREASED
|
0.00%
0/32 • 12 months
|
7.3%
3/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Infections and infestations
PNEUMONIA
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Infections and infestations
RHINITIS
|
9.4%
3/32 • 12 months
|
14.6%
6/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Infections and infestations
SINUSITIS
|
6.2%
2/32 • 12 months
|
4.9%
2/41 • 12 months
|
2.6%
1/38 • 12 months
|
|
Skin and subcutaneous tissue disorders
CONTACT DERMATITIS
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
6.2%
2/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Eye disorders
AMD PROGRESSION (Fellow eye)
|
15.6%
5/32 • 12 months
|
14.6%
6/41 • 12 months
|
18.4%
7/38 • 12 months
|
|
Eye disorders
BLEPHARITIS (Fellow eye)
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
CATARACT (Fellow eye)
|
9.4%
3/32 • 12 months
|
9.8%
4/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
CONJUNCTIVITIS (Fellow eye)
|
6.2%
2/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
DRY EYES (Fellow eye)
|
3.1%
1/32 • 12 months
|
2.4%
1/41 • 12 months
|
10.5%
4/38 • 12 months
|
|
Eye disorders
EYE DISORDER (Fellow eye)
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
EYE ITCHING (Fellow eye)
|
6.2%
2/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Eye disorders
RETINAL DISORDER (Fellow eye)
|
6.2%
2/32 • 12 months
|
7.3%
3/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
RETINAL HEMORRHAGE (Fellow eye)
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
SUBRETINAL HEMORRHAGE (Fellow eye)
|
6.2%
2/32 • 12 months
|
0.00%
0/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Ear and labyrinth disorders
TINNITUS
|
0.00%
0/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
VISION DECREASED (Fellow eye)
|
0.00%
0/32 • 12 months
|
2.4%
1/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
ACUTE ELEVATED IOP (Study eye)
|
6.2%
2/32 • 12 months
|
17.1%
7/41 • 12 months
|
0.00%
0/38 • 12 months
|
|
Eye disorders
AMD PROGRESSION (Study eye)
|
18.8%
6/32 • 12 months
|
19.5%
8/41 • 12 months
|
7.9%
3/38 • 12 months
|
|
Eye disorders
BLEPHARITIS (Study eye)
|
3.1%
1/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
CATARACT (Study eye)
|
25.0%
8/32 • 12 months
|
24.4%
10/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
CONJUNCTIVITIS (Study eye)
|
9.4%
3/32 • 12 months
|
0.00%
0/41 • 12 months
|
5.3%
2/38 • 12 months
|
|
Eye disorders
DRY EYES (Study eye)
|
3.1%
1/32 • 12 months
|
4.9%
2/41 • 12 months
|
10.5%
4/38 • 12 months
|
|
Eye disorders
EYE HEMORRHAGE (Study eye)
|
15.6%
5/32 • 12 months
|
17.1%
7/41 • 12 months
|
18.4%
7/38 • 12 months
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862 778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER