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OpenTrials
Completed

NCT Number: NCT04847895

Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications

This study is designed as an observational, non-interventional, multicenter, open label, single arm study in patients being treated with Lucentis® for any approved indication included in the local product posology.

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Key information

Conditions

Neovascular (Wet) Age-related Macular Degeneration Cardiovascular Diseases Choroid Diseases Choroidal Neovascularization Embolism and Thrombosis Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Uveal Diseases Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Ettlingen, Baden-Wurttemberg, Germany

Loading trial locations.

About this study

The prospective observation period per patient will be up to 24 months. A minimum of one follow-up visit per year is required in order to maintain patient's participation in the study.

The baseline visit will be used to assess eligibility and collect baseline characteristics information. The follow-up visits will take place at a frequency defined as per investigator's discretion.

The study eye is defined as the first eye treated during the study, the other eye will be considered as the fellow eye. If both eyes are treated at baseline, the right eye will be chosen as the study eye.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female patients, ≥18 years of age, being treated with Lucentis® for any approved indication in the local Lucentis® SmPC
  • Written informed consent

Exclusion criteria

  • As described in Lucentis® SmPC
  • Participation in any other clinical study or NIS with Lucentis® as the investigational drug (such as OCEAN or LUMINOUS)

Treatment and study plan

Lucentis

Drug

There is no treatment allocation. Patients administered Lucentis by prescription that have started before inclusion of the patient into the study will be enrolled.

Primary outcomes

  1. mean change in visual acuity

    Time frame: Baseline, Up to month 24

    Visual acuity will be measured according to the method used by each participating physician in his/her routine practice. To be able to integrate different visual acuity assessment methods for analysis, visual acuity assessments performed using Snellen or decimal notation will be converted into an Early Treatment Diabetic Retinopathy Study (ETDRS) letter score equivalent.

  2. mean change in central retinal thickness

    Time frame: Baseline, Up to month 24

    As central retinal thickness data is optional, this analysis will be performed only if data allow.

Secondary outcomes

  1. Number of treatments

    Time frame: Up to 24 months

    Number of treatments will be provided

  2. Number of visits

    Time frame: Up to 24 months

    Number of visits will be provided

  3. Time interval between treatments

    Time frame: Up to 24 months

    Time interval between treatments will be provided

  4. Time interval between visits

    Time frame: Up to 24 months

    Time interval between visits will be provided

  5. Duration of treatment period

    Time frame: Up to 24 months

    Duration of treatment period will be provided

  6. Maximum period of treatment extension

    Time frame: Up to 24 months

    Maximum period of treatment extension (where applicable)

  7. Number of retreatments

    Time frame: Up to 24 months

    Number of retreatments will be provided

  8. Reasons for retreatment

    Time frame: Up to 24 months

    Reasons for retreatment will be provided

  9. Monitoring and treatment regimen - Therapy schemes

    Time frame: Up to 24 months

    The following therapy schemes are defined:

    • Fixed scheme (FIX): Planned interval of (control-) visits: "regular" and planned treatment performance: "at each visit"
    • Pro Re Nata (PRN): Planned interval of (control-) visits: "regular" and planned treatment performance: "as needed"
    • Treat & Extend (T+E): Planned interval of (control-) visits: "variable" and planned treatment performance: "at each visit"
    • Monitor & Extend (M+E): Planned interval of (control-) visits: "variable" and planned treatment performance: "as needed"

    FIX, PRN, T+E and M+E are based on documentation by visit regarding physician's planning and will be applied as overall planned therapy scheme, if no different therapy schemes are documented between patient's visit.

    Actual interval of (control-) visits and treatment performance will be derived using the documented visit dates and treatment documentations.

  10. Reasons for choice of treatment regimen

    Time frame: Up to 24 months

    Reasons for choice of treatment regimen will be provided. The choice of treatment is described within 5 categories:

    • Medical reasons
    • Compability with organisation of practice/clinic
    • Compability with availability of patient
    • Patient's request
    • Other

  11. Monitoring and treatment patterns as a function of health insurances

    Time frame: Up to 24 months

    The results from the above derived monitoring and treatment regimen will be stratified for German patients according to the status of insurance (public health insurance or private health insurance).

  12. Number of treatments with Lucentis® vials and pre-filled syringe

    Time frame: Up to 24 months

    Number of treatments with Lucentis® vials and pre-filled syringe will be provided

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Observation of Treatment Patterns With Lucentis® (Ranibizumab) in Real-life Conditions in All Approved Indications

Acronym: PACIFIC

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Apr 19, 2021

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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