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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 ADMINISTERED THROUGH 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 PHYSICIAN. THE INTENTION IS TO KEEP THE IMPLANT IN THE EYE PERMANENTLY, UNLESS IT NEEDS TO BE REMOVED FOR MEDICAL REASONS.
- PHASE IIIB, GLOBAL, MULTICENTER, RANDOMIZED, MULTICENTER, BLINDED TO VISUAL EVALUATOR, PHASE IIIB 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)
- Code EudraCT: 2020-001313-20
- Protocol number: WR42221
- Promoter: Roche Farma, S.A.
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