CompletedPhase 3

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

China114 participantsStarted 2009-01

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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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.

What they're measuring

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.

Timeframe: 12 months

Trial details

NCT IDNCT00826371

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-07

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