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Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting (LUMINOUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01318941
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : May 23, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date March 17, 2011
First Posted Date March 21, 2011
Last Update Posted Date May 23, 2016
Study Start Date March 2011
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 13, 2015)
  • 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 Measures
 (submitted: March 17, 2011)
Mean Visual Acuity (VA) and mean change in VA [ Time Frame: 3,6, and 12 months from the baseline visit, and annually thereafter ]
Change History
Current Secondary Outcome Measures
 (submitted: February 13, 2015)
  • 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 Measures
 (submitted: March 17, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting
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 Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Outpatient ophthalmology Clinics
Condition
  • Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
  • Wet Age Related Macular Degeneration
  • Diabetic Macular Edema
  • Retinal Vein Occlusion
Intervention
  • Drug: Ranibizumab
  • Other: Ranibizumab
Study Groups/Cohorts Ranibizumab
Interventions:
  • Drug: Ranibizumab
  • Other: Ranibizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 20, 2016)
30490
Original Estimated Enrollment
 (submitted: March 17, 2011)
30000
Actual Study Completion Date April 2016
Actual Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients, within age limits as defined by local regulations and local product label, who have previously been treated with, who are currently being treated with or initiating treatment with ranibizumab for any approved indication included in the local product label
  • Willing and able to provide informed written consent personally or by legal proxy

Exclusion Criteria:

  • Simultaneous participation in a study that includes administration of any investigational drug or procedure
  • Systemic or ocular treatment with any VEGF inhibitor other than ranibizumab in the 90 days prior to enrollment
  • Other protocol-defined inclusion/exclusion criteria may apply
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Costa Rica,   Czech Republic,   Dominican Republic,   Ecuador,   Egypt,   France,   Germany,   Greece,   Guatemala,   Hong Kong,   Hungary,   India,   Ireland,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Panama,   Peru,   Poland,   Portugal,   Russian Federation,   Saudi Arabia,   Singapore,   Slovakia,   Slovenia,   Spain,   Turkey,   Ukraine,   United Kingdom,   Venezuela
Removed Location Countries  
 
Administrative Information
NCT Number NCT01318941
Other Study ID Numbers CRFB002A2406
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor Novartis Pharmaceuticals
Collaborators Not Provided
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date May 2016