A phase 3b, randomized, active controlled, double-masked, single dummy, multi-center comparative trial, in parallel groups, to compare the safety and efficacy of intravenous injections of MacugenTM given every 6 weeks for 54 weeks (to be extended to 102 weeks as indicated) plus sham photodynamic therapy (PDT), to MacugenTM plus PDT with visudyne, in subjects with predominantly classic subfoveal choroidal neuvascolarization (CNV) secondary to age-related macular degeneration (AMD).
- Conditions
- Predominantly classic subfoveal choroidal neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD).MedDRA version: 6.1Level: PTClassification code 10055666
- Registration Number
- EUCTR2004-004867-31-IT
- Lead Sponsor
- PFIZER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 360
Inclusion Criteria
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method