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Clinical trial of IONIS-FB-LRX in patients with geographic atrophy secondary to age-related macular degeneration.

THE STUDY DRUG IS DESIGNED TO SLOW THE BODY'S PRODUCTION OF A PROTEIN CALLED FACTOR B (FB); THIS PROTEIN IS PRODUCED IN THE LIVER AND CAN BE DETECTED IN THE EYE, WHICH MAY CONTRIBUTE TO GA SECONDARY TO AMD. THIS STUDY WILL ALSO COMPARE THE STUDY DRUG TO A PLACEBO. A PLACEBO IS AN INACTIVE SUBSTANCE THAT DOES NOT CONTAIN ANY DRUG; IT LOOKS LIKE THE ACTUAL STUDY DRUG, BUT IT IS NOT. IN ADDITION, WE WANT TO ESTABLISH THE SAFETY AND TOLERABILITY OF THE STUDY DRUG. WE WANT TO KNOW WHAT EFFECTS (GOOD OR BAD) VARIOUS DIFFERENT DOSES OF THE STUDY DRUG HAVE ON GA SECONDARY TO AMD IN PATIENTS 50 YEARS OF AGE AND OLDER. THIS STUDY WILL ALSO MEASURE THE AMOUNT OF STUDY DRUG IN YOUR BLOOD AT VARIOUS TIMES AND CHECK HOW LONG THE STUDY DRUG STAYS IN YOUR BODY.

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • PHASE II, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF MULTIPLE DOSES OF IONIS-FB-LRX, A COMPLEMENT FACTOR B ANTISENSE INHIBITOR, IN PATIENTS WITH GEOGRAPHIC ATROPHY SECONDARY TO AGE-RELATED MACULAR DEGENERATION (AMD)
  • Code EudraCT: 2015-001837-25
  • Protocol number: 696844-CS5
  • Promoter: Ionis Pharmaceutical
  • 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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