Phase 3
N=321
Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
Macular Degeneration · Choroidal Neovascularization
Bottom Line
View on ClinicalTrials.gov: NCT00436553 ↗Enrolled (actual)
321
Serious AEs
31.8%
Results posted
Apr 2011
Primary outcome: Primary: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12 — 53.7; 54.6; 54.8; 59.0 Letters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Verteporfin Photodynamic Therapy (Drug); Ranibizumab (Drug); Verteporfin Placebo (Drug); Ranibizumab Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12 |
53.7; 54.6; 54.8; 59.0; 59.0; 63.0 | — |
| PRIMARY Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit |
92.6; 83.5 | — |
| SECONDARY Change From Baseline in Total Area of Leakage of the Study Eye at Month 12 |
6.654; 6.211; 6.931; 3.472; 3.024; 3.177 | — |
| SECONDARY Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12 |
58.2; 54.5; 41.8 | — |
| SECONDARY Change From Baseline in Central Retinal Thickness at Month 12 |
444.654; 446.638; 456.824; 292.921; 305.719; 284.586 | — |
Summary
This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.
Eligibility Criteria
Inclusion Criteria
- Subjects of either gender age 50 years or older
- Subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD)
Exclusion Criteria
- Choroidal neovascularization due to causes other than AMD
- Prior treatment for neovascular AMD in the study eye
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT00436553). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.