GX29639 - PROXIMA Study B

• 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

  168378

• Contact name

  Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR

• Contact email

  global.eudract@roche.com

• Sponsor organisation

  F Hoffmann-La Roche Ltd

• Duration of Study in the UK

  6 years, 5 months, 22 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.
  Currently, there are no approved treatments to prevent the worsening of GA or the associated decline in vision.
  This main purpose of this study is to evaluate the progression of GA as measured by Fundus Auto Fluorescence (FAF) and to evaluate the prognostic value of the complement factor I (CFI) profile biomarker on the mean change in the GA area from baseline as measured by FAF. This is a global, prospective, multicenter, epidemiologic study with an enrollment target of 200 patients with GA secondary to AMD. The duration of patients’ follow-up is dependent on the future availability of approved treatment for GA; in the absence of an approved therapy, patients follow up in this study is planned for up to 60 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), the Day 1 visit, and the study period of 60 months.
  In the UK, it is expected that 20 patients will be enrolled from 4 participating centres.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  15/NE/0089

• Date of REC Opinion

  29 Apr 2015

• REC opinion

  Further Information Favourable Opinion