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

This study is currently recruiting participants.
Verified February 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01318941
First received: March 17, 2011
Last updated: February 4, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Wet Age Related Macular Degeneration
Diabetic Macular Edema
Retinal Vein Occlusion
 Other: Ranibizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: LUMINOUS: Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Mean visual acuity at quarterly intervals for the primary treated eye set [ Time Frame: Quarterly intervals from baseline visit during study duration (5 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30000
Study Start Date: March 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ranibizumab Other: Ranibizumab

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Outpatient ophthalmology Clinics

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01318941

Contacts
Contact: Novartis Pharma AG +41-61-324-1111

  Show 59 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharma Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01318941     History of Changes
Other Study ID Numbers: RFB002A2406
Study First Received: March 17, 2011
Last Updated: February 4, 2013
Health Authority: Austria: AGES
Germany: BfArm
Poland: UPRL
Slovakia: SUKL
Singapore: Health Sciences Authority

Keywords provided by Novartis:
Ophthalmology
Age-related macular degeneration
Diabetic Macular Edema
 Retinal Vein Occlusion
LUMINOUS
Ranibizumab

Additional relevant MeSH terms:
Edema
Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013