Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

Completed

• Conditions: Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion; Retinal Vein Occlusion; Diabetic Macular Edema; Wet Age Related Macular Degeneration
• Interventions: Other: Ranibizumab

• Registration Number: NCT01318941
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-17
• Study First Submitted QC: 2011-03-17
• Study First Posted: 2011-03-21
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-20
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30490

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Ranibizumab	-

Primary Outcome Measures

Name	Time	Method
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)
Mean Visual Acuity (VA) and mean change in VA	3,6, and 12 months from the baseline visit, and annually thereafter

Secondary Outcome Measures

Name	Time	Method
"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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇻🇪 Torre Venezuela, Piso 1, Venezuela