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

Age Related Macular Degeneration Clinical Trial

— EXTEND II  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826371
• Other study ID #: CRFB002A2203
• Status: Completed
• Phase: Phase 3
• First received: January 16, 2009
• Last updated: November 16, 2016
• Start date: January 2009

Study information

• Verified date: November 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics CommitteeChina: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration

Intervention

Drug:
• ranibizumab 0.5 mg

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigational Site	Chengdu
China	Novartis Investigative Site	Guangzhou
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

References & Publications (1)

Zhao J, Li X, Tang S, Xu G, Xu X, Zhang F, Zhang M, Shamsazar J, Pilz S, Nieweg A. EXTEND II: an open-label phase III multicentre study to evaluate efficacy and safety of ranibizumab in Chinese patients with subfoveal choroidal neovascularization secondar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the effects of ranibizumab 0.5 mg on the change in BCVA from Baseline to Month 12.		12 Months	No
Secondary	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	No
Secondary	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	Yes

External Links

•   Results for CRFB002A2203 from the Novartis Clinical Trials Website