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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01318941
First received: March 17, 2011
Last updated: February 13, 2015
Last verified: February 2015
  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
Wet Age Related Macular Degeneration
Diabetic Macular Edema
Retinal Vein Occlusion
Drug: Ranibizumab
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:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean Visual Acuity (VA) and mean change in VA [ Time Frame: 3,6, and 12 months from the baseline visit, and annually thereafter ] [ Designated as safety issue: No ]
  • 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:
  • 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 ] [ Designated as safety issue: Yes ]
  • Number of ranibizumab injections administered per patient, per eye, and per person-year [ Time Frame: annually ] [ Designated as safety issue: Yes ]
  • "National Eye Institute Visual Functioning Questionnaire-25" change from baseline [ Time Frame: annually ] [ Designated as safety issue: Yes ]
  • 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: 26146
Study Start Date: March 2011
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Ranibizumab Drug: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

  Show 644 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01318941     History of Changes
Other Study ID Numbers: CRFB002A2406
Study First Received: March 17, 2011
Last Updated: February 13, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Singapore: HAS
Austria: AGES
Germany: BfArm
Poland: UPRL
Slovakia: SUKL
Singapore: Health Sciences Authority
Costa Rica: Ethics Committee
Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)
Guatemala: Ministry of Public Health and Social Assistance
Panama: Ministry of Health

Keywords provided by Novartis:
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:
Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Retinal Degeneration
Retinal Diseases
Thrombosis
Vascular Diseases
Venous Thrombosis

ClinicalTrials.gov processed this record on March 25, 2015