A randomized controlled multicentre study to assess the non-inferiority of the safety of bevacizumab compared to ranibizumab administered by intravitreal injection in patients with macular degeneration or other exudative not age-related macular
Phase 1
- Conditions
- - Age-related macular degeneration- Diabetic retinal oedema- Retinal perivascular sheathing- Choroidal neovascularisationTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-000133-12-IT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1780
Inclusion Criteria
1. Age-related macular degeneration
or Diabetic retinal oedema
or Retinal perivascular sheathing
or Choroidal neovascularisation
patients
2. Men/woman
3. age = 18 years
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 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1500
Exclusion Criteria
1. Patients treated with anti-VEGF intravitreal within the last six months
prior the inclusion in the study
2. Pregnancy or breast-feending
3. Patients in emergency situation
4. Subjects inable to give informed consent
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