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)

• 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: Novartis Pharmaceuticals
• 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

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
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.

Baseline Characteristics

Arm/Group Title		Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.
Description	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decrease in score indicates worsening of vision. This outcome assessed the percentage of participants who lost less than 15 letters of visual acuity at 12 months as compared with baseline.
Time Frame	Baseline to Month 12

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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
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

Outcome Measure Data

Analysis Population Description

Observed data.

Arm/Group Title	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib
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
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

Outcome Measure Data

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
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)

Adverse Events

Time Frame	12 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib
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	--/--	--/--	--/--
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)
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)

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

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