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”

To evaluate the safety and efficacy of the combination treatments in wet age-related macular degeneration

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Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

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Intervention(s) in this Clinical Trial

• Drug: intravenous verteporfin, plus intravitreal (intraocular) injection of drug of either triamcinolone acetonide or pegaptanib sodium

Primary Measures

• Loss of visual acuity scroe less than 15 lettres from baseline at month 12

Secondary Measures

• Gain of viusal acuity score equal or more than 5,10,and 15 lettres from baseline at months 6, 12 and 24
• Loss of visual acuity score less than 15 lettres from baseline at month 6 and 24
• Requirement of verteporfin treatments throughout the study after baseline
• Changes in best-corrected visual acuity at months 3, 6 and 12
• Changes in total size of lesions at month 3,6 and 12

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

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Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharma Study Chair Novartis Customer Information  

Information obtained from ClinicalTrials

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Link to the current ClinicalTrials

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Study ID Number: CBPD952E2202

ClinicalTrials

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Health Authority: United States: Food and Drug Administration

Novartis patient recruitment website: Clinical trial information for patients and caregivers