Clinical Trial: Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

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

Official Title: A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in

Brief Summary: This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye [ Time Frame: Baseline, Month 1 through Month 3 ]

Original Primary Outcome: Average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 3 and the baseline level of BCVA. [ Time Frame: 6 and 12 Months ]

Current Secondary Outcome:

• Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye [ Time Frame: Baseline and Month 6 ]
  The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet.
• Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye [ Time Frame: Baseline and Month 1 through Month 12 ]
  The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12
• Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3 [ Time Frame: Month 3 ]
  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 more than 10 or more than 15 of visual acuity at month 3.
• Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12 [ Time Frame: Months 6 and 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 increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.
• Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3 [ Time Frame: Month 3 ]
  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 decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.
• Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12 [ Time Frame: Months 6 and 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. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.
• Change From Baseline in Central Retinal Thickness of the Study Eye Over Time [ Time Frame: Baseline, Month 3, Month 6 and Month 12 ]
  Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.
• Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye [ Time Frame: Baseline and Month 12 ]
  CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators.
• Number of Ranibizumab Injections Received Prior to Month 3 [ Time Frame: Day 1 and prior to month 3 ]
  In order to describe exposure to the study drug the number of ejections was evaluated
• Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period [ Time Frame: Day 1 prior to month 6 and prior to month 12 ]
  Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period
• Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period [ Time Frame: Month 3 up to month 12 ]
  Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.

Original Secondary Outcome:

• Difference between the average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 6 and the baseline level of BCVA. [ Time Frame: 6 and 12 months ]
• Average level of BCVA (letters) over all monthly post-baseline assessments from Month 1 to Month 12 and the baseline level of BCVA and based on the time course of BCVA changes from baseline [ Time Frame: 6 and 12 months ]
• Compare the proportion of patients with ≥10 and ≥15 letters gain or reaching 84 letters, and ≥10 and ≥15 letters loss for each month between treatment groups [ Time Frame: 6 and 12 months ]
• Compare the proportion of patients with presence of active leakage over time up to Month 12 in the treatment groups [ Time Frame: 6 and 12 months ]
• Number, severity, and relationship to the study drug of the Adverse events as measure of safety and tolerability of 0.5 mg ranibizumab (two regimens) vs. vPDT at Month 3, Month 6 and Month 12. [ Time Frame: 6 and 12 months ]

Dates:
Date Received: October 6, 2010
Date Started: October 2010
Date Completion:
Last Updated: January 14, 2014
Last Verified: January 2014