Trials / Terminated
TerminatedNCT00433017
Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)
24-month Randomized, Double-masked, Controlled, Multicenter, Phase II Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab Versus Ranibizumab Monotherapy in Patients With Subfoveal Choroidal Neovascularization Secondary to AMD.
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 255 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Verteporfin Photodynamic Therapy | After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m\^2 body surface area, verteporfin was activated by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of the infusion. |
| DRUG | Ranibizumab | Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection |
| DRUG | Placebo | As a placebo for verteporfin photodynamic therapy (for masking purposes), patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm\^2 to the study eye, begun 15 minutes after the start of infusion. |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2009-07-01
- Completion
- 2009-07-01
- First posted
- 2007-02-09
- Last updated
- 2011-04-21
- Results posted
- 2011-02-04
Locations
12 sites across 12 countries: Austria, Belgium, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT00433017. Inclusion in this directory is not an endorsement.