GX29633 - PROXIMA Study A

• Research type

  Research Study

• Full title

  A MULTICENTER, PROSPECTIVE EPIDEMIOLOGIC STUDY OF THE PROGRESSION OF GEOGRAPHIC ATROPHY SECONDARY TO AGERELATED MACULAR DEGENERATION

• IRAS ID

  168377

• Contact name

  Head, EU/ROW Regulatory Affairs Pharmaceutical Division

• Contact email

  welwyn.eudract@roche.com

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Duration of Study in the UK

  5 years, 5 months, 23 days

• Research summary

  Agerelated macular degeneration (AMD) is the leading cause of irreversible blindness in people aged 50 years or older in the developed world. The majority of the visual loss occurs in the advanced stage of AMD. Geographic atrophy (GA) is one form of the condition, which is characterised by loss of blood vessels to the retina, layers of cells that contain pigment, and photoreceptors in the retina.

  The main purpose of this study is to generate a better understanding of the variability and dynamic range of visual function tests over time and how these changes correlate with changes in geographic atrophy (GA) area in patients with GA secondary to age related macular degeneration (AMD).

  This is a global, prospective, multicenter, epidemiologic study with an enrollment target of 360 patients with GA secondary to AMD. The population will be enriched for the CFI profile biomarker positive patients at a 2:1 ratio which treatment a participant receives will be decided by chance by a computer. The duration of study patients’ follow-up is dependent on the potential future availability of approved treatments for GA; in the absence of an approved therapy, patients’ follow-up in this study is planned for up to 48 months. Visual function and anatomic measures will be collected at screening, baseline (Day 1), and every 6 months thereafter. Information concerning clinical events that occur during the study termed medical events of interest will be collected through a checklist administered at each scheduled and unscheduled visit. The study will consist of a screening period of up to 28 days (Days 28 to 1), Day 1 visit, and the study period of 48 months.

  In the UK, it is expected that 30 patients will be enrolled from 6 participating centres.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  15/NE/0088

• Date of REC Opinion

  29 Apr 2015

• REC opinion

  Further Information Favourable Opinion