An observational study in Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, Wet Age Related Macular Degeneration and Diabetic Macular Edema, sponsored by Novartis Pharmaceuticals. Completed at 463 sites in 43 countries. Per ClinicalTrials.gov, last updated 2016-05-23.
Sponsored by Novartis Pharmaceuticals · Observational
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.
26 studies on the registry are indexed under Papilledema; 6 are open to participants now.
Browse Papilledema studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Outpatient ophthalmology Clinics
Exclusion Criteria:
Drug: Ranibizumab · Other: Ranibizumab
Mean Visual Acuity (VA) and mean change in VA
Time frame: 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
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)
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
Number of ranibizumab injections administered per patient, per eye, and per person-year
Time frame: annually
"National Eye Institute Visual Functioning Questionnaire-25" change from baseline
Time frame: 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
Time frame: Over time during study duration (5 years)
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)
Showing the first 100 of 463 sites across 43 countries.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Novartis Pharmaceuticals