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 - Full Text View

Sponsor:	Novartis Pharmaceuticals
Collaborator:	QLT Inc
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00242580

Purpose

To evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration. The combination treatment consists of verteporfin photodynamic therapy and either triamcinolone acetonide or pegaptanib added as an intravitreal injection.

Condition	Intervention	Phase
Macular Degeneration Choroidal Neovascularization	Drug: Verteporfin and triamcinolone 1 mg Drug: Verteporfin and triamcinolone 4 mg Drug: Verteporfin and Pegaptanib	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Verteporfin Pegaptanib sodium Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Loss of visual acuity scroe less than 15 lettres from baseline at month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Gain of viusal acuity score equal or more than 5,10,and 15 lettres from baseline at months 6, 12 and 24 [ Time Frame: Month 6, 12 and 24 ] [ Designated as safety issue: No ]
Loss of visual acuity score less than 15 lettres from baseline at month 6 and 24 [ Time Frame: Month 6 and 24 ] [ Designated as safety issue: No ]
Requirement of verteporfin treatments throughout the study after baseline [ Time Frame: after baseline ] [ Designated as safety issue: No ]
Changes in best-corrected visual acuity at months 3, 6 and 12 [ Time Frame: Month 3, 6 and 12 ] [ Designated as safety issue: No ]
Changes in total size of lesions at month 3,6 and 12 [ Time Frame: Month 3, 6 and 12 ] [ Designated as safety issue: No ]

Enrollment:	139
Study Start Date:	September 2005
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Verteporfin and triamcinolone 1 mg
2: Active Comparator	Drug: Verteporfin and triamcinolone 4 mg
3: Active Comparator	Drug: Verteporfin and Pegaptanib

Detailed Description:

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Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

age >50
all types of untreated subfoveal choroidal neovascularization secondary to AMD
lesion size <5400 microns in greater linear dimension (GLD)

Exclusion Criteria:

have a history of prior photodynamic therapy, external beam radiation, subfoveal focal laser photocoagulation, submacular surgery, or transpupillary thermotherapy
known allergy to verteporfin, triamcinolone or pegaptanib
recent eye surgery (within the last 2 months)

Other protocol-specified inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242580

Locations

United States, Texas
Novartis Investigational Site
Austin, Texas, United States, 78793

Sponsors and Collaborators

Novartis Pharmaceuticals

QLT Inc

Investigators

Study Chair:

Novartis Pharmaceuticals

More Information

Additional Information:

Novartis patient recruitment website: Clinical trial information for patients and caregivers This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CBPD952E2202
Study First Received:	October 19, 2005
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00242580 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

AMD
age-related macular degeneration
choroidal neovascularization

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Triamcinolone hexacetonide
Triamcinolone Acetonide
Pathologic Processes
Metaplasia
Therapeutic Uses
Triamcinolone
Dermatologic Agents
Retinal Diseases
Uveal Diseases

Eye Diseases
Choroid Diseases
Verteporfin
Retinal Degeneration
Macular Degeneration
Triamcinolone diacetate
Enzyme Inhibitors
Glucocorticoids
Immunosuppressive Agents
Pharmacologic Actions
Choroidal Neovascularization
Photosensitizing Agents
Radiation-Sensitizing Agents
Neovascularization, Pathologic

ClinicalTrials.gov processed this record on February 08, 2010