Safety and Efficacy of Ranibizumab in Japanese Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

This study has been completed.

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00284089

Purpose

The purpose of this study is to investigate the safety, efficacy, and pharmacokinetics of ranibizumab in the treatment of subfoveal CNV secondary to AMD

Condition	Intervention	Phase
Subfoveal Choroidal Neovascularization(CNV) Secondary to Age-Related Macular Degeneration (AMD)	Drug: Ranibizumab	Phase I Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Open-Label Multicenter, Phase I/II Study Assessing the Safety and Efficacy of Ranibizumab (RFB002) in Japanese Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

Further study details as provided by Novartis:

Study Start Date:

April 2005

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria
1. Male or female patients 50 years of age or greater
2. Patients with primary or recurrent subfoveal CNV secondary to AMD
3. Patients who have a BCVA score between 73 and 24 letters in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320)
Exclusion criteria
1. No prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00284089

Locations

Japan
Novartis
Tokio, Japan

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Customer Information

Novartis

More Information

Study ID Numbers:	CRFB002A1201
Study First Received:	January 30, 2006
Last Updated:	November 17, 2006
ClinicalTrials.gov Identifier:	NCT00284089
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Subfoveal CNV, AMD, ranibizumab

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Neoplasm Metastasis
Retinal Degeneration

Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Neoplasms
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009