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Observation of Treatment Patterns With Lucentis in Approved Indications (OCEAN)

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ClinicalTrials.gov Identifier: NCT02194803
Recruitment Status : Completed
First Posted : July 18, 2014
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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
Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV

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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 : December 8, 2011
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Group/Cohort
Cohort with routine OCT monitoring
Cohort without routine OCT monitoring



Primary Outcome Measures :
  1. Change from Baseline in Visual Acuity (VA) to Month 12 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Male and female patients suffering from neovascular eye pathology in real life setting for whom a therapy with Lucentis® is recommended by the treating physician in line with approved indications. Warnings and contraindications have to be taken into account according to the summary of product characteristics (SmPC).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02194803


Locations
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Germany
Novartis Investigative Site
Tübingen, Germany, 72076
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02194803    
Other Study ID Numbers: CRFB002ADE18
First Posted: July 18, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Vision Disorders
Vision, Low
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases