Comparison of the long-term efficacy and safety of Lucentis versus Ozurdex in patients with visual impairment due to macular edema following retinal vein occlusion (central or branch vein) who have completed the respective core study (CRFB002EDE17 or CRFB002EDE18)
- Conditions
- visual impairment due to macular edema following retinal vein occlusion (branch or central)MedDRA version: 14.1Level: LLTClassification code 10054467Term: Macular edemaSystem Organ Class: 10015919 - Eye disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2011-005045-13-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients must have completed the core study assessments at month 6 of study CRFB002EDE17 or CRFB002EDE18, respectively.
2. Signed Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
1.Patients who experienced an uncontrollable rise in IOP during the core study CRFB002EDE17 respectively CRFB002EDE18, i.e. IOP could not be decreased to a stable level of < 25mmHg.
2. Current use or likely need of systemic medications known to be toxic to the lens, retina or optic nerve
3.History of hypersensitivity to Ranibizumab or Ozurdex or any component of the ranibizumab respectively Ozurdey formulation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method