Last updated on June 2019

Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis in Patients With nAMD

Brief description of study

The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

Detailed Study Description

This is a phase III multicenter, double-masked, randomized, parallel group study in subjects with wAMD. Approximately 580 subjects will be enrolled and randomized in a 1:1 ratio to receive either Lucentis or the investigational product, Xlucane in the study eye once every 4 weeks for 52 weeks. The study eye will be defined as the eye meeting the enrollment criteria. The assigned study drug will be administered as an ophthalmic intravitreal (IVT) injection. A subgroup of 60 subjects at a select number of participating sites will be sequentially asked to participate in an evaluation of PK.

Clinical Study Identifier: NCT03805100

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Retina Centers P.C

Tucson, AZ United States
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Win Retina

Arcadia, CA United States
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The Retina Partners

Encino, CA United States
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Mark B. Kislinger MD Inc.

Glendora, CA United States
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Atlantis Eyecare

Huntington Beach, CA United States
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Fort Lauderdale Eye Institute

Fort Lauderdale, FL United States
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Sarasota Retina Institute

Sarasota, FL United States
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Southeast Retina Center

Augusta, GA United States
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Georgia Retina

Marietta, GA United States
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Gailey Eye Clinic

Bloomington, IL United States
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Sabates Eye Centers

Leawood, KS United States
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Austin Retina Associates

Austin, TX United States
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Houston Eye Associates

Houston, TX United States
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Retina Consultants of Houston

The Woodlands, TX United States
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Recruitment Status: Open

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