MACTEL Type 2_ NTMT-03 phase 3 trial

• Research type

  Research Study

• Full title

  A Phase III Multicentre Randomised, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus in Macular Telangiectasia Type 2

• IRAS ID

  239092

• Contact name

  Catherine Egan

• Contact email

  Catherine.Egan@moorfields.nhs.uk

• Sponsor organisation

  Neurotech Pharmaceuticals

• Eudract number

  2017-003234-82

• Clinicaltrials.gov Identifier

  NCT03316300

• Duration of Study in the UK

  3 years, 0 months, 0 days

• Research summary

  Research Summary:

  Macular telangiectasia type 2 (MacTel) is a bilateral disease of unknown cause with characteristic alterations of the macular-capillary network and neurosensory atrophy of the retina. The disease usually presents between ages 50 and 60 in both men and women. There appear to be two factors contributing to the decline of visual function. Initially there may be a slow drop in visual acuity due to structural foveal changes associated with chronic low grade vascular leak. The more important factor is atrophy of the foveal photoreceptors. Renexus® is designed to continuously release ciliary neurotrophic factor (CNTF) which may have a protective effect on photoreceptors. The goal of the study is to investigate the effect of CNTF on MacTel by measuring the change in the size of the area of photoreceptor loss over two years.
  112 Patient will be randomized (1:1) to receive the Renexus® implant or sham procedure in the study-eligible eye. All participants will be followed through 24 months.

  Summary of Results:
  Please see for summary of results on https://www.clinicaltrialsregister.eu/ctr-search/trial/2017-003234-82/results

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  18/SC/0151

• Date of REC Opinion

  13 Jun 2018

• REC opinion

  Further Information Favourable Opinion