Diabetic Macular Edema, Retinal Vein Occlusion, Wet Age Related Macular Degeneration, Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
Conditions
Keywords
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
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.
Interventions
DRUGRanibizumab
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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) |
| 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 |
| 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 |
| National Eye Institute Visual Functioning Questionnaire-25 change from baseline | annually |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czechia, Dominican Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Panama, Peru, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Turkey (Türkiye), Ukraine, United Kingdom, Venezuela
Outcome results
None listed