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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 )

Study Description
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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.

Condition or disease Intervention/treatment
Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion Wet Age Related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion Drug: Ranibizumab Other: Ranibizumab

Study Design
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Study Type : Observational
Actual Enrollment : 30490 participants
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
Study Start Date : March 2011
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Ranibizumab Drug: Ranibizumab
Other: Ranibizumab


Outcome Measures
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Primary Outcome Measures :
  1. Mean Visual Acuity (VA) and mean change in VA [ Time Frame: 3,6, and 12 months from the baseline visit, and annually thereafter ]
  2. 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 ]
  3. Mean visual acuity at quarterly intervals for the primary treated eye set [ Time Frame: Quarterly intervals from baseline visit during study duration (5 years) ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of ranibizumab injections administered per patient, per eye, and per person-year [ Time Frame: annually ]
  3. "National Eye Institute Visual Functioning Questionnaire-25" change from baseline [ Time Frame: annually ]
  4. 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) ]
  5. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318941


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01318941    
Other Study ID Numbers: CRFB002A2406
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: May 23, 2016
Last Verified: May 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Ophthalmology, age-related macular degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, ranibizumab
Ophthalmology
Age-related macular degeneration
Diabetic Macular Edema
 Retinal Vein Occlusion
LUMINOUS
Ranibizumab
Additional relevant MeSH terms:
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Papilledema
Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Edema
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
 Cardiovascular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Nervous System Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents