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OpenTrials
Completed

NCT Number: NCT01318941

Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

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.

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Key information

Conditions

Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion Cardiovascular Diseases Diabetic Macular Edema Embolism and Thrombosis Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis Wet Age Related Macular Degeneration

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

Ranibizumab

Other

Primary outcomes

  1. Mean Visual Acuity (VA) and mean change in VA

    Time frame: 3,6, and 12 months from the baseline visit, and annually thereafter

  2. 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

  3. 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

  1. 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

  2. Number of ranibizumab injections administered per patient, per eye, and per person-year

    Time frame: annually

  3. "National Eye Institute Visual Functioning Questionnaire-25" change from baseline

    Time frame: annually

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Acronym: LUMINOUS

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Mar 21, 2011
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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