Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

Novartis Pharmaceuticals30,490 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

30,490

Conditions

Interventions

RanibizumabDRUG

RanibizumabOTHER

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (463)

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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Novartis Investigative Site

Buenos Aires, Argentina, Argentina

Novartis Investigative Site

Concepción del Uruguay, Argentina, Argentina

Novartis Investigative Site

Córdoba, Argentina, Argentina

Novartis Investigative Site

Guaymallén, Mendoza, Argentina, Argentina

Novartis Investigative Site

Rosario, Argentina, Argentina

Novartis Investigative Site

San Martin, Buenos Aires, Argentina, Argentina

Novartis Investigative Site

Santa Fe, Argentina, Argentina

Novartis Investigative Site

Lanús, Buenos Aires, Argentina

Novartis Investigative Site

Mar del Plata, Buenos Aires, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

...and 453 more locations