Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Novartis Pharmaceuticals |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00826371 |
The purpose of the study is to provide efficacy and safety data for monthly ranibizumab 0.5 mg intravitreal injections in Chinese patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study results will support the regulatory submission in China to make ranibizumab available for clinical use.
Condition | Intervention | Phase |
---|---|---|
Age Related Macular Degeneration |
Drug: ranibizumab 0.5 mg |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment |
Official Title: | An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ranibizumab (0.5 mg) in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration Over 12 Months |
Estimated Enrollment: | 110 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental | Drug: ranibizumab 0.5 mg |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Contact: Novartis Pharmaceuticals | +41-61-324-1111 |
China | |
Novartis Investigational Site | Recruiting |
Chengdu, China, 610041 | |
Novartis Investigative Site | Not yet recruiting |
Beijing, China, 100730 | |
Novartis Investigative Site | Not yet recruiting |
Beijing, China, 100044 | |
Novartis Investigative Site | Not yet recruiting |
Guangzhou, China, 510060 | |
Novartis Investigative Site | Not yet recruiting |
Shanghai, China, 200031 | |
Novartis Investigative Site | Recruiting |
Shanghai, China, 200080 | |
Novartis Investigative Site | Recruiting |
Beijing, China, 100730 |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CRFB002A2203 |
Study First Received: | January 16, 2009 |
Last Updated: | February 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00826371 History of Changes |
Health Authority: | China: Ethics Committee; China: Ministry of Health |
AMD Ranibizumab |
Metaplasia Eye Diseases Choroid Diseases Neoplasm Metastasis Retinal Degeneration |
Macular Degeneration Neovascularization, Pathologic Retinal Diseases Choroidal Neovascularization |
Uveal Diseases Pathologic Processes Metaplasia Eye Diseases Choroid Diseases |
Retinal Degeneration Macular Degeneration Neovascularization, Pathologic Retinal Diseases Choroidal Neovascularization |