DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Macular Degeneration; Choroidal Neovascularization

Intervention: Verteporfin photodynamic therapy (Drug); Pegaptanib (Drug); Triamcinolone acetonide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis Pharmaceuticals


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Percentage of Participants Who Lose Less Than 15 Letters of Best Corrected Visual Acuity (BCVA) at 12 Months From Baseline.

Secondary outcome:

Percentage of Participants With Gain of 5 or More Letters of Best Corrected Visual Acuity From Baseline to Month 12

Percentage of Participants With Gain of BCVA of 10 or More Letters at 12 Months

Percentage of Participants With Gain of BCVA Score of 15 or More Letters at Month 12

Number of Participants Requiring Verteporfin Treatment Throughout the Study

Mean Change From Baseline in Total Area of Lesion at 12 Months


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

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

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

Starting date: September 2005
Last updated: April 1, 2011

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017