Clinical Trial: Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)

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

Official Title: A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Central

Brief Summary: Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Average Change in Visual Acuity (Letters) From Baseline to Month 1 Through Month 3 [ Time Frame: Baseline, 3 Months ]

Original Primary Outcome: Change of Best Corrected Visual Acuity (BCVA) in patients treated with ranibizumab 0.5 mg prn or sham injection [ Time Frame: Baseline, 3 Months ]

Current Secondary Outcome:

• Average Change of Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 12 [ Time Frame: Baseline, 12 months ]
  Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline
• Best Corrected Visual Acuity (BCVA) Change From Baseline Over Time [ Time Frame: Month 1 to 12 months ]
  Visual acuity (VA) was assessed on both eyes during every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes the change in visual acuity at each visit compared to baseline
• Change From Baseline in Central-Sub-Field- Thickness (CSFT) Over Time [ Time Frame: Month 1 to month 12 ]
  OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center.
• Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time [ Time Frame: Month 1 to month 12 ]
  Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters.
• Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of <15 Letters in the Study Eye Over Time [ Time Frame: Month 1 to 12 months ]
  Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.
• The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline [ Time Frame: Month 3,6 and 12 ]
  The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.

Original Secondary Outcome:

• Average change of Best Corrected Visual Acuity (BCVA) in patients treated with ranibizumab 0.5 mg prn [ Time Frame: Baseline, 12 months ]
  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. The overall BCVA score was calculated using the BCVA worksheet.
• Best Corrected Visual Acuity (BCVA) change over time [ Time Frame: 12 months ]
  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. The overall BCVA score was calculated using the BCVA worksheet.
• Change in Central-Sub-Field- Thickness (CSFT) [ Time Frame: Baseline, 12 Months ]
  Retinal thickness was assessed by Optical Coherence Tomography (OCT) and was analyzed by the central reading center.
• Categorical BCVA improvement over time [ Time Frame: 12 months ]
  BCVA improvement of >= 5, >= 10, >=15 and >= 30 letters from baseline over time (month 1 through month 12)
• Percentage of patients with Best Corrected Visual Acuity (BCVA) loss < 15 letter [ Time Frame: 12 months ]
  BCVA loss < 15 letters from baseline over time (month 1 through month 12)
• The Change in Patient Reported Outcomes in NEI-VFQ-25 Score (Composite Score and Subscales) at Month 3, 6 and 12 Compared to Baseline [ Time Frame: Baseline, month 3,6 and 12 ]
  Effect of treatment on absolute composite- and subscale scores and changes from baseline over time of vision related quality of life assessed by the patient on the Vision Functioning Questionaire (VFQ-25)"
• Number of paticipants with Adverse Events as a measure of Safety and Tolerability [ Time Frame: 12 months ]
• Number of re-treatments and re-treatment patterns [ Time Frame: 12 months ]
  Number of re-treatments and re-treatment patterns (eg: duration of treatment-free intervals; duration of active treatment phase)

Dates:
Date Received: October 18, 2013
Date Started: November 12, 2013
Date Completion:
Last Updated: March 13, 2017
Last Verified: March 2017