Trials / Completed
CompletedNCT01217944
Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 277 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ranibizumab | 0.5 mg ranibizumab intravitreal injection |
| DRUG | Verteporfin PDT | Verteporfin (6 mg/m2) intravenous infusion |
| DRUG | Sham Ranibizumab | Empty vial to mimic the intravitreal injection |
| DRUG | Sham verteporfin PDT | Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT). |
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
- First posted
- 2010-10-08
- Last updated
- 2014-02-10
- Results posted
- 2013-10-18
Locations
74 sites across 20 countries: Austria, Canada, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Latvia, Lithuania, Poland, Portugal, Singapore, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT01217944. Inclusion in this directory is not an endorsement.