Observation of Treatment Patterns With Lucentis in Approved Indications

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

— OCEAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02194803
• Other study ID #: CRFB002ADE18
• Status: Completed
• Phase: N/A
• First received: June 11, 2014
• Last updated: February 28, 2017
• Start date: December 8, 2011
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5778
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Visual Acuity (VA) to 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.	Baseline, Month 12
Primary	Change from Baseline in Visual Acuity (VA) to 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.	Baseline, Month 24