drugset / Trial / NCT00284089
Safety and Efficacy of Ranibizumab in Japanese Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
RandomizedParallel-groupOpen-labelTreatment
Summary
Open-label Multicenter, Phase I/II Study comprising three phases (single dose, multiple dose and extension phase), Assessing the Safety and Efficacy of Ranibizumab (RFB002) in Japanese Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD).
Timeline
- Start
- 2005-04
- Primary completion
- 2007-03
- Completion
- 2009-01
Outcome
Met primary endpoint
paper Mean change from baseline in BCVA was significantly increased for both doses (Group B) at Month 6 PMID 20163368 ↗
paper 0.3 mg: +8.1 letters, p = 0.0006 PMID 20163368 ↗
paper 0.5 mg: +9.0 letters, p < 0.0001 PMID 20163368 ↗
Publications
- Results Tano Y, Ohji M; EXTEND-I Study Group. EXTEND-I: safety and efficacy of ranibizumab in Japanese patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Acta Ophthalmol. 2010 May;88(3):309-16. doi: 10.1111/j.1755-3768.2009.01843.x. Epub 2010 Feb 16.
- Results Tano Y, Ohji M; EXTEND-I Study Group. Long-term efficacy and safety of ranibizumab administered pro re nata in Japanese patients with neovascular age-related macular degeneration in the EXTEND-I study. Acta Ophthalmol. 2011 May;89(3):208-17. doi: 10.1111/j.1755-3768.2010.02065.x. Epub 2011 Jan 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ranibizumab | Monoclonal antibody | 0.3 mg | Intravitreal |
| Subject | Ranibizumab | Monoclonal antibody | 0.5 mg | Intravitreal |