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)

This study has been completed.

Sponsor:

Collaborator:

QLT Inc.

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00242580

First received: October 19, 2005

Last updated: April 1, 2011

Last verified: April 2011

History of Changes

Results First Received: January 24, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Macular Degeneration Choroidal Neovascularization
Interventions:	Drug: Verteporfin photodynamic therapy Drug: Pegaptanib Drug: Triamcinolone acetonide

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
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.

Participant Flow: Overall Study

	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib
STARTED	32	41	38
COMPLETED	22 ^[1]	29	24
NOT COMPLETED	10	12	14
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
Adminstrative problems	0	0	0
Death	1	2	1

[1]	"Completed" indicates 12 month data.

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	Verteporfin + 1 mg Triamcinolone	Verteporfin + 4 mg Triamcinolone	Verteporfin + Pegaptanib	Total
Number of Participants [units: participants]	32	41	38	111
Age [units: years] Mean ± Standard Deviation	76 ± 9	78 ± 8	81 ± 6	78 ± 8
Gender [units: participants]
Female	18	25	20	63
Male	14	16	18	48
Region of Enrollment [units: participants]
United States	32	41	38	111

Outcome Measures

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1. Primary:

Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline. [ Time Frame: Baseline to Month 12 ]

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2. Secondary:

Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12 [ Time Frame: Baseline to Month 12 ]

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3. Secondary:

Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months [ Time Frame: Baseline to Month 12 ]

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4. Secondary:

Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12 [ Time Frame: Baseline to Month 12 ]

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5. Secondary:

Number of Participants Requiring Verteporfin Treatment Throughout the Study [ Time Frame: Baseline to Month 12 ]

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6. Secondary:

Mean Change From Baseline in Total Area of Lesion at 12 Months [ Time Frame: Baseline to Month 12 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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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 agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00242580 History of Changes
Other Study ID Numbers:	CBPD952E2202
Study First Received:	October 19, 2005
Results First Received:	January 24, 2011
Last Updated:	April 1, 2011
Health Authority:	United States: Food and Drug Administration

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