Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Ranibizumab
* Other: Ranibizumab


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ranibizumab<br> | Drug: Ranibizumab<br> <br> Other: Ranibizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Visual Acuity (VA) and mean change in VA |  | 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 |  | 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 |  | Quarterly intervals from baseline visit during study duration (5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of ranibizumab injections administered per patient, per eye, and per person-year |  | annually | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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