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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Ra

Brief 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.

Detailed Summary:
Sponsor: Novartis

Current Primary Outcome:

  • Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12 [ Time Frame: Baseline and Month 12 ]
    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 increase in the VA score indicates improvement in visual acuity.
  • Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit [ Time Frame: Month 2 up to Month 11 ]
    The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.


Original Primary Outcome:

  • Change from baseline in Best-Corrected Visual Acuity (BCVA) (letters) at Month 12
  • Treatment-free interval of at least 3 months duration until Month 12


Current Secondary Outcome:

  • Change From Baseline in Total Area of Leakage of the Study Eye at Month 12 [ Time Frame: Baseline and Month 12 ]
    Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
  • Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12 [ Time Frame: Month 12 ]
    The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).
  • Change From Baseline in Central Retinal Thickness at Month 12 [ Time Frame: Baseline and Month 12 ]
    Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.


Original Secondary Outcome:

  • • Retreatment pattern of combination therapy until Month 12/24 based on the time to first retreatment, the number of retreatment, and the proportion of patients with a treatment-free interval of at least 3 months duration until Month 24
  • Safety of combination therapy and monotherapy over 24 months
  • Changes in Best Corrected Visual Acuity from baseline over 24 months
  • Angiographic and optical coherence tomography (OCT) outcomes from baseline over 24 months
  • Onset of effect assessed by change from baseline in BCVA at Months 1, 2 and 3


Information By: Novartis

Dates:
Date Received: February 16, 2007
Date Started: February 2007
Date Completion:
Last Updated: March 23, 2011
Last Verified: March 2011