Evaluation of Safety and Efficacy of Once Monthly Ranibizumab Injections in Chinese Patients With Wet Age Related Macular Degeneration (AMD) Patients - Full Text View

Sponsored by:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00826371

Purpose

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

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, 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

Further study details as provided by Novartis:

Primary Outcome Measures:

To evaluate efficacy of ranibizumab 0.5 mg by mean change in best-corrected visual acuity (BCVA) from Baseline to Month 4 as assessed with early treatment of diabetic retinopathy study (ETDRS) like charts at a distance of 4 meters. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
To evaluate effects of ranibizumab 0.5 mg on retinal structure at Month 4 and Month 12 as assessed by fundus photography, fluorescein angiography, and optical coherence tomography. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
To evaluate safety of ranibizumab 0.5 mg by rates of adverse events/SAEs, ophthalmic exams, tonometry, and changes in laboratory values/vital signs at Months 4 and 12. [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

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

Eligibility

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

Criteria

Inclusion Criteria:

Male or female Chinese patients 50 years of age or greater.
Patients with primary or recurrent subfoveal CNV secondary to AMD.
Patients who have a BCVA score from 73 to 24 characters in the study eye.

Exclusion Criteria:

Active, or history of, ocular inflammation or infection in the study eye within the last 30 days.
Uncontrolled glaucoma in the study eye.

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826371

Contacts

Contact: Novartis Pharmaceuticals

+41-61-324-1111

Locations

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

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

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

Keywords provided by Novartis:

AMD
Ranibizumab

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Neoplasm Metastasis
Retinal Degeneration

Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

Additional relevant MeSH terms:

Uveal Diseases
Pathologic Processes
Metaplasia
Eye Diseases
Choroid Diseases

Retinal Degeneration
Macular Degeneration
Neovascularization, Pathologic
Retinal Diseases
Choroidal Neovascularization

ClinicalTrials.gov processed this record on May 06, 2009