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Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization

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); Ranibizumab (Drug); Verteporfin Placebo (Drug); Ranibizumab Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

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

Summary

This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.

Clinical Details

Official title: A 24-month Randomized, Double-masked, Controlled, Multicenter, Phase IIIB Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab Versus Ranibizumab Monotherapy 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:

Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12

Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit

Secondary outcome:

Change From Baseline in Total Area of Leakage of the Study Eye at Month 12

Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12

Change From Baseline in Central Retinal Thickness at Month 12

Eligibility

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

Criteria:

Inclusion Criteria:

- Subjects of either gender age 50 years or older

- Subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration

(AMD) Exclusion Criteria:

- Choroidal neovascularization due to causes other than AMD

- Prior treatment for neovascular AMD in the study eye

Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Novartis Investigative Site, Edmonton, Alberta T5H OX5, Canada

Novartis Investigative Site, Tucson, Arizona 85704, United States

Novartis Investigative Site, Vancouver, British Columbia V5Z 3N9, Canada

Novartis Investigative Site, Beverly Hills, California 90211, United States

Novartis Investigative Site, Oakland, California 94609, United States

Novartis Investigative Site, Pasadena, California 91105-3153, United States

Novartis Investigative Site, Sacramento, California 95819, United States

West Coast Retina Medical Group Inc. - 185 Berry St. Suite 130, San Francisco, California 94107, United States

Novartis Investigative Site, Santa Ana, California 92705, United States

Novartis Investigative Site, Denver, Colorado 80210, United States

Novartis Investigative Site, Aiea, Hawaii 96701, United States

Novartis Investigative Site, Iowa City, Iowa 52242, United States

Novartis Investigative Site, Wichita, Kansas 67214, United States

Novartis Investigative Site, Lexington, Kentucky 40509, United States

Novartis Investigative Site, Paducah, Kentucky 42001, United States

Novartis Investigative Site, Baltimore, Maryland 21205, United States

Novartis Investigative Site, Grand Rapids, Michigan 49252, United States

Novartis Investigative SIte, Royal Oak, Michigan 48073, United States

Novartis Investigative Site, Williamsburg, Michigan 49690, United States

Novartis Investigative Site, Independence, Missouri 64055, United States

Novartis Investigative Site, St. Louis, Missouri 63110, United States

Novartis Investigative Site, Toms River, New Jersey 08755, United States

Novartis Investigative Site, Lynbrook, New York 11563, United States

Novartis Investigative Site, Rochester, New York 14620, United States

Novartis Investigative Site, Halifax, Nova Scotia B3H 2Y6, Canada

Novartis Investigative Site, Beachwood, Ohio 44122, United States

Novartis Investigative Site, Cincinnati, Ohio 45242, United States

Novartis Investigative Site, Cleveland, Ohio 44195, United States

Ivey Eye Institute, Dr. Thomas Sheidow, London, Ontario N6A 4G5, Canada

Novartis Investigative Site, London, Ontario N6A 4G5, Canada

Novartis Investigative Site, Ottawa, Ontario KIH 8L6, Canada

Novartis Investigative Site, Pittsburgh, Pennsylvania 15213, United States

Novartis Investigative Site, West Mifflin, Pennsylvania 15122, United States

Novartis Investigative Site, Montreal, Quebec H2L 4MI, Canada

Novartis Investigative Site, West Columbia, South Carolina 29169, United States

Novartis Investigative Site, Rapid City, South Dakota 57701, United States

Novartis Investigative Site, Kingsport, Tennessee 37660, United States

Novartis Investigative Site, Knoxville, Tennessee 37909, United States

Novartis Investigative Site, Austin, Texas 78705, United States

Novartis Investigative Site, Houston, Texas 77030, United States

Novartis Investigative Site, Fairfax, Virginia 22031, United States

Novartis Investigative Site, Richmond, Virginia 23226, United States

Novartis Investigative Site, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: February 2007
Last updated: March 23, 2011

Page last updated: August 23, 2015

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