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

Novartis

Status and phase: Completed; Phase 3

Conditions: Age Related Macular Degeneration

Treatments: Drug: ranibizumab 0.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00826371

CRFB002A2203

Details and patient eligibility

About

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.

Enrollment: 114 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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114 participants in 1 patient group

1

Experimental group

Treatment:

Drug: ranibizumab 0.5 mg