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Clinical trial of SOK583A1 versus intravitreal Eylea® in patients with neovascular age-related macular degeneration

THIS STUDY IS A BIOSIMILAR STUDY, WHICH MEANS THAT TWO TREATMENTS WITH THE SAME ACTIVE INGREDIENT WILL BE COMPARED. SOK583A1 IS AN INVESTIGATIONAL NEW PRODUCT BEING DEVELOPED AS A CHEMICAL EQUIVALENT OF EYLEA®, A TREATMENT ALREADY APPROVED IN ADULTS FOR THE TREATMENT OF AMDEN IN MANY COUNTRIES. THE PURPOSE OF THIS STUDY IS TO DEMONSTRATE THAT SOK583A1 IS AS EFFECTIVE AS EYLEA® IN PARTICIPANTS WITH AMDEN.

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • MULTICENTER, RANDOMIZED, DOUBLE-MASKED, DOUBLE-BLIND, PARALLEL-GROUP, 52-WEEK STUDY TO COMPARE THE EFFICACY, SAFETY AND IMMUNOGENICITY OF SOK583A1 TO EYLEA® ADMINISTERED INTRAVITREALLY IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION.
  • Code EudraCT: CSOK583A12301
  • Protocol number: CSOK583A12301
  • Promoter: HexaL AG and Sandoz Inc
  • Link to Clinical Trials

* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.

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