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Clinical trial of ranibizumab in patients with neovascular age-related macular degeneration

THE PURPOSE OF THIS STUDY IS TO EVALUATE THE EFFECTS, GOOD OR BAD, OF RANIBIZUMAB DELIVERED VIA AN OCULAR IMPLANT (ALSO KNOWN AS A PORT DELIVERY SYSTEM WITH RANIBIZUMAB OR PDS DEVICE) IN PATIENTS WITH WET AMD. THE OCULAR IMPLANT DELIVERS RANIBIZUMAB CONTINUOUSLY (WITHOUT INTERRUPTION) OVER AN EXTENDED PERIOD OF TIME TO THE BACK OF THE EYE AND CAN BE RECHARGED BY THE STUDY DOCTOR. 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/Madrid

Technical Summary

  • PHASE IIIB, GLOBAL, MULTICENTRE, RANDOMISED, MULTICENTRE, BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF RANIBIZUMAB ADMINISTERED WITH THE PORT DELIVERY SYSTEM DEVICE USING A 36-WEEKLY REFILL SCHEDULE IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (VELODROME). IMMUNOTHERAPY
  • Code EudraCT: 2020-001313-20
  • Protocol number: WR42221
  • Promoter: Roche Farma, S.A.

* 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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