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

Phase 3

Completed

• Conditions: Age Related Macular Degeneration
• Interventions: Drug: ranibizumab 0.5 mg

• Registration Number: NCT00826371
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-16
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2010-07
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-16
• Last Update Posted: 2016-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ranibizumab 0.5 mg	-

Primary Outcome Measures

Name	Time	Method
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.	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Novartis Investigational Site; 🇨🇳 Chengdu, China

Novartis Investigative Site; 🇨🇳 Shanghai, China