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OCEAN: Observation of Treatment Patterns With Lucentis in Approved Indications

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT02194803
Collaborator
(none)
5,778
Enrollment
1
Location
60.8
Actual Duration (Months)
95.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A multicentre, open-label, non-interventional study to observe treatment patterns in patients with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to chorioidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a 24 months observational period under real life conditions.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    5778 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications
    Actual Study Start Date :
    Dec 8, 2011
    Actual Primary Completion Date :
    Dec 31, 2016
    Actual Study Completion Date :
    Dec 31, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Cohort with routine OCT monitoring
    Cohort without routine OCT monitoring

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Visual Acuity (VA) to Month 12 [Baseline, Month 12]

      Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.

    2. Change from Baseline in Visual Acuity (VA) to Month 24 [Baseline, Month 24]

      Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Presence of

    • neovascular (wet) age-related macular degeneration (AMD),

    • visual impairment due to diabetic macular oedema (DME),

    • visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) or

    • visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM)

    • Patients for whom a therapy with Lucentis® is medically indicated.

    • Written patients informed consent.

    Exclusion criteria:

    • As described in the SmPC.

    • Preceding intravitreal treatment of the study eye with anti-VEGF drugs in the last three months before enrollment

    • Preceding intravitreal treatment of the study eye with steroids

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Investigative Site Tübingen Germany 72076

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT02194803
    Other Study ID Numbers:
    • CRFB002ADE18
    First Posted:
    Jul 18, 2014
    Last Update Posted:
    Mar 1, 2017
    Last Verified:
    Feb 1, 2017
    Additional relevant MeSH terms:
    Vision Disorders
    Vision, Low
    Macular Edema

    Study Results

    No Results Posted as of Mar 1, 2017