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Clinical trial of ALXN2040 in patients with geographic atrophy secondary to age-related macular degeneration.

MACULAR DEGENERATION IS A DISORDER THAT AFFECTS THE CENTRAL PART OF THE RETINA (THE MACULA) AND CAUSES A LOSS OF CENTRAL VISION. IT OCCURS ESPECIALLY IN OLDER PEOPLE AND IS THEREFORE CALLED AMD. AGE-RELATED MACULAR DEGENERATION IS A MAJOR CAUSE OF BLINDNESS AND HAS 2 ADVANCED FORMS OF THE DISEASE: (1) NEOVASCULAR AMD (WET FORM), IN WHICH PERMEABLE BLOOD VESSELS GROW UNDER THE RETINA (A LAYER AT THE BACK OF THE EYEBALL THAT CONTAINS LIGHT-SENSITIVE CELLS AND TRIGGERS THE SIGNAL THAT PASSES THROUGH THE OPTIC NERVE TO THE BRAIN, WHERE A VISUAL IMAGE IS FORMED) AND (2) GA (DRY FORM), IN WHICH THE LIGHT-SENSITIVE CELLS OF THE RETINA DISAPPEAR AND DIE (ATROPHY). REGIONS OF ATROPHY RESULT IN A BLIND SPOT IN THE VISUAL FIELD. THE EFFECT OF THE DISEASE ON VISION PROGRESSES SLOWLY AND MAY DIFFER FROM PATIENT TO PATIENT, DEPENDING ON WHERE IN THE RETINA THE ATROPHY OCCURS AND THE SIZE OF THE AREA OF ATROPHY. PATIENTS MAY NOTICE DIFFICULTIES WITH FACIAL RECOGNITION, DIFFICULTY DRIVING, DELAY IN SEEING THINGS IN A DARK ENVIRONMENT, BLACK SPOTS IN THE VISUAL FIELD, AND DECREASED READING SPEED. THE OBJECTIVES OF THIS STUDY ARE AS FOLLOWS: - TO FIND OUT IF DANICOPAN CAN SLOW THE RATE OF GA PROGRESSION AND, IN TURN, THE LOSS OF VISUAL FUNCTION. - TO DETERMINE THE SAFETY OF DANICOPAN IN PATIENTS WITH GA BY MONITORING FOR POSSIBLE SIDE EFFECTS. - TO TEST HOW THE BODY RESPONDS TO TREATMENT WITH DANICOPAN. - MEASURE THE BLOOD CONCENTRATION OF DANICOPAN OVER TIME. - FIND A SAFE AND EFFECTIVE DOSE IN PATIENTS WITH GA AND FIND OUT HOW THE BODY RESPONDS TO THE STUDY DRUG AT DIFFERENT DOSES. - TO TEST THE EFFECT OF DANICOPAN ON HEALTH-RELATED QUALITY OF LIFE, ACTIVITIES OF DAILY LIVING AND VISUAL FUNCTIONS.

Navarre headquarters
Madrid headquarters
Status
In recruitment
headquarters
Pamplona

Technical Summary

  • PHASE 2, DOUBLE-MASKED, PLACEBO-CONTROLLED, PLACEBO-CONTROLLED, DOSE-FINDING STUDY OF DANICOPAN (ALXN2040) IN PATIENTS WITH GEOGRAPHIC ATROPHY (GA) SECONDARY TO AGE-RELATED MACULAR DEGENERATION (AMD).
  • Code EudraCT: .
  • Protocol number: ALXN2040-GA-201
  • Promoter: Alexion Pharmaceuticals, Inc.
  • Link to Clinical Trials

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