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 photodynamic therapy Drug: Pegaptanib Drug: Triamcinolone acetonide	Phase III

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
Official Title:	A 24-month Randomized, Double-masked, Sham Controlled, Multicenter, Phase IIIB Study Comparing Photodynamic Therapy With Verteporfin (Visudyne®) Plus Two Different Dose Regimens of Intravitreal Triamcinolone Acetonide (1 mg and 4 mg) Versus Visudyne® Plus Intravitreal Pegaptanib(Macugen®) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration 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:

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 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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.
Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
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.
Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
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.
Number of Participants Requiring Verteporfin Treatment Throughout the Study [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
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.
Mean Change From Baseline in Total Area of Lesion at 12 Months [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
Fluorescein angiography (FA) was used to assess total lesion area. All angiographs were sent to the Central Reading Center (CRC) for analysis.

Enrollment:	111
Study Start Date:	September 2005
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Verteporfin and Triamcinolone 1 mg 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.	Drug: Verteporfin photodynamic therapy After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion. Other Name: Visudyne Drug: Triamcinolone acetonide Triamcinolone acetonide administered by intravitreal injection. Other Name: Kenalog-40®
Experimental: Verteporfin and Triamcinolone 4 mg 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.	Drug: Verteporfin photodynamic therapy After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion. Other Name: Visudyne Drug: Triamcinolone acetonide Triamcinolone acetonide administered by intravitreal injection. Other Name: Kenalog-40®
Active Comparator: Verteporfin and 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.	Drug: Verteporfin photodynamic therapy After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion. Other Name: Visudyne Drug: Pegaptanib Pegaptanib sodium 0.3 mg administered by intravitreal injection. Other Name: Macugen

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
have received prior treatment with Macugen, or other anti-angiogenic compound or any investigational treatment (e.g. Ruboxistaurin, Lucentis [ranibizumab], Retaane [anecortave acetate], squalamine, siRNA, VEGF-Trap etc.) for neovascular AMD
have the presence of fibrosis, hemorrhage, pigment epithelial detachments, tear (tip) of the retinal pigment epithelium or other hypoflourescent lesions obscuring greater than 50% of the CNV lesion
have had previous pars plana vitrectomy in the study eye

Other protocol-specified inclusion/exclusion criteria applied.

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:	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

Keywords provided by Novartis:

AMD
age-related macular degeneration
choroidal neovascularization

Additional relevant MeSH terms:

Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Verteporfin

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Photosensitizing Agents
Radiation-Sensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on February 09, 2012