Observation of Treatment Patterns With Lucentis in Approved Indications

N/ACompletedNCT02194803

Novartis Pharmaceuticals5,778 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

5,778

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Month 12

Change from Baseline in Visual Acuity (VA) to Month 24

Time frame: Baseline, Month 24