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Trial to evaluate the long-term safety and tolerability of the port delivery system device with ranibizumab in patients with neovascular age-related macular degeneration.

THE PURPOSE OF THIS STUDY IS TO EVALUATE THE LONG-TERM EFFECTS, GOOD OR BAD, OF THE OCULAR IMPLANT (IN THE EYE) IN YOU AND YOUR WET AMD, WHEREBY A DOSE OF RANIBIZUMAB IS ADMINISTERED. THE OCULAR IMPLANT DELIVERS RANIBIZUMAB CONTINUOUSLY (WITHOUT INTERRUPTIONS) OVER AN EXTENDED PERIOD OF TIME INTO THE BACK OF THE EYE AND CAN BE RECHARGED BY THE STUDY DOCTOR. SINCE THE IMPLANT RELEASES RANIBIZUMAB OVER TIME, IT MAY NOT NEED TO BE TREATED AS FREQUENTLY. THE INTENTION IS TO KEEP THE IMPLANT IN THE EYE PERMANENTLY, UNLESS IT NEEDS TO BE REMOVED FOR MEDICAL REASONS.

Navarre headquarters
Madrid headquarters
Status
In recruitment
headquarters
Pamplona

Technical Summary

  • OPEN-LABEL, MULTICENTER EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF THE RANIBIZUMAB-CONTAINING PORT DELIVERY SYSTEM DEVICE IN PATIENTS WITH NEOVASCULAR (PORTAL) AGE-RELATED MACULAR DEGENERATION. IMMUNOTHERAPY
  • Code EudraCT: 2020-004427-16
  • Protocol number: GR40549
  • Promoter: Roche Farma, S.A.
  • 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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