Clinical Trial: Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: LUMINOUS: Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes

Brief Summary: This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

  • Mean Visual Acuity (VA) and mean change in VA [ Time Frame: 3,6, and 12 months from the baseline visit, and annually thereafter ]
  • Incidence rate, relationship and severity of treatment emergent ocular and non-ocular adverse events [ Time Frame: Defined time periods during study duration from FPFV until 30 days after LPLV ]
  • Mean visual acuity at quarterly intervals for the primary treated eye set [ Time Frame: Quarterly intervals from baseline visit during study duration (5 years) ]


Original Primary Outcome: Mean Visual Acuity (VA) and mean change in VA [ Time Frame: 3,6, and 12 months from the baseline visit, and annually thereafter ]

Current Secondary Outcome:

  • Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the time the patient signed the informed consent until 30 days after study discontinuation ]
  • Number of ranibizumab injections administered per patient, per eye, and per person-year [ Time Frame: annually ]
  • "National Eye Institute Visual Functioning Questionnaire-25" change from baseline [ Time Frame: annually ]
  • Overall number of ranibizumab injections, number of visits, time interval between injections, duration of treatment, number of re-treatment, and reasons for treatment termination [ Time Frame: Over time during study duration (5 years) ]
  • Change from baseline in National Eye Institute Visual Function Questionnaire 25 composite and sub-scale scores [ Time Frame: Over time during study duration (5 years) ]


Original Secondary Outcome:

  • Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: From the time the patient signed the informed consent until 30 days after study discontinuation ]
  • Number of ranibizumab injections administered per patient, per eye, and per person-year [ Time Frame: annually ]
  • "National Eye Institute Visual Functioning Questionnaire-25" change from baseline [ Time Frame: annually ]


Information By: Novartis

Dates:
Date Received: March 17, 2011
Date Started: March 2011
Date Completion:
Last Updated: May 20, 2016
Last Verified: May 2016