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

Novartis

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT02194803

CRFB002ADE18

Details and patient eligibility

About

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.

Enrollment: 5,778 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,778 participants in 2 patient groups

Cohort with routine OCT monitoring

Cohort without routine OCT monitoring