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

Novartis Pharmaceuticals2 sites in 1 country114 target enrollmentJanuary 2009

ConditionsAge Related Macular Degeneration

Interventionsranibizumab 0.5 mg

Drugsranibizumab 0.5 mg

Overview

Phase: Phase 3
Intervention: ranibizumab 0.5 mg
Conditions: Age Related Macular Degeneration
Sponsor: Novartis Pharmaceuticals
Enrollment: 114
Locations: 2
Primary Endpoint: 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.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

July 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Eligibility 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.

Arms & Interventions

1

Intervention: ranibizumab 0.5 mg

Outcomes

Primary Outcomes

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

Secondary Outcomes

To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12.(12 Months)
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.(12 Months)
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.(12 Months)