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OpenTrials
Completed

NCT Number: NCT02194803

Observation of Treatment Patterns With Lucentis in Approved Indications

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Observation of Treatment Patterns With Lucentis and Real Life Ophthalmic Monitoring, Including Optional OCT in Approved Indications

Acronym: OCEAN

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jul 18, 2014
Registry last updated
Mar 1, 2017

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.