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

Novartis Pharmaceuticals1 site in 1 country30,490 target enrollmentMarch 2011

ConditionsWet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion Wet Age Related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion

InterventionsRanibizumab

DrugsRanibizumab

Overview

Phase: Not Applicable
Intervention: Ranibizumab
Conditions: Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
Sponsor: Novartis Pharmaceuticals
Enrollment: 30490
Locations: 1
Primary Endpoint: Incidence rate, relationship and severity of treatment emergent ocular and non-ocular adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

April 2016

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

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

Arms & Interventions

Ranibizumab

Intervention: Ranibizumab

Outcomes

Primary Outcomes

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)

Mean Visual Acuity (VA) and mean change in VA

Time Frame: 3,6, and 12 months from the baseline visit, and annually thereafter

Secondary Outcomes

"National Eye Institute Visual Functioning Questionnaire-25" change from baseline(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(Over time during study duration (5 years))
Change from baseline in National Eye Institute Visual Function Questionnaire 25 composite and sub-scale scores(Over time during study duration (5 years))
Number of ranibizumab injections administered per patient, per eye, and per person-year(annually)
Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)(From the time the patient signed the informed consent until 30 days after study discontinuation)