PRO_010-2023, v1.0

• Research type

  Research Study

• Full title

  A prospective multicenter clinical study to evaluate the safety and effectiveness of intrastomal implantation of the Transform corneal Allograft (TCA) for providing near vision in presbyopic subjects - Long term follow-up

• IRAS ID

  335749

• Contact name

  Sheraz Daya

• Contact email

  sdaya@centreforsight.com

• Sponsor organisation

  Allotex Inc.

• Clinicaltrials.gov Identifier

  NCT06310252

• Duration of Study in the UK

  0 years, 4 months, 1 days

• Research summary

  Research Summary

  The objective of this clinical study is to evaluate the long-term safety and effectiveness of the Allotex TransForm corneal allograft (TCA) for improving near vision in presbyopic subjects.

  Patients previously implanted with the Allotex TCA will undergo a single, non-invasive examination visit to assess the safety and effectiveness of the inlay four years after implantation.

  Summary of Results

  Study title: A PROSPECTIVE MULTICENTER CLINICAL STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF INTRASTROMAL IMPLANTATION OF THE TRANSFORMTM CORNEAL ALLOGRAFT (TCA) FOR PROVIDING NEAR VISION IN PRESBYOPIC SUBJECTS-LONG TERM FOLLOW-UP

  Sponsor: Allotex, Inc.
  27-43 Wormwood Street
  Boston, MA 02210
  United States

  Medical Monitor: Vance Thompson, MD
  Vance Thompson Vision
  3101 W. 57th Street
  Sioux Falls, SD 57108 USA
  Telephone: (605) 359-4070
  Email: vance.thompson@vancethompsonvision.com

  The study was conducted from 13/02/2024 to 11/11/2024 at the following sites:
  1- Wellington Eye Clinic, Beacon Court, Level 2, Ste 36 Beacon Hall, Sandyford, Dublin, D18 T8P3, Ireland
  2- TEM Avrupa otoyolu göztepe çıkışı no:1, 34214 Bağcılar/İstanbul, Türkiye
  3- Eye Clinic London, 22 Wimpole Street, London, W1G 8GQ, United Kingdom
  4- Centre for Sight, Hazelden Place, Turners Hill Rd, East Grinstead RH19 4RH, United Kingdom
  5- U Gemini 360, 760 01 Zlín – Příluky, Czech Republic

  Study design and objective: This is a prospective, single-armed, non-masked, non-randomized, multicenter, observational, clinical trial to evaluate the long-term safety and effectiveness of intrastromal implantation of the Allotex TransForm corneal allograft (TCA) for providing near vision in presbyopic subjects.

  Study description: The TCA is indicated for intrastromal implantation to provide near vision in the non-dominant eye of presbyopic patients. A maximum of 101 eyes of qualified and consented subjects who previously participated in the PRO_010 study were enrolled under a separate protocol, PRO_010-2023, to explore the durability of treatment and the long-term safety of the implant 4 to 5 years after implantation.

  Study results: The long-term study outcomes did not identify new or major risks that were previously unidentified. The most frequent adverse event was loss of best corrected acuity at distance and/or near greater than two lines, occurring in 22.5% (16/71) of subjects. Importantly, both best corrected distance visual acuity (BCDVA) and best corrected near visual acuity (BCNVA) were 20/40 or better in all subjects. Seven of the 16 subjects had concurrent lens opacities noted during slit lamp examination. Five of the 16 subjects had Tear break-up time (TBUT) less than 5 seconds, which is associated with decreased vision.

  Conclusion: In summary, the results of the long-term study support a favorable safety profile to perform further clinical evaluation of the TCA corneal allograft under a feasibility protocol utilizing learnings from this PRO_010/PRO_010-2023 study cohort.

  No further research is planned.
  

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  24/WM/0084

• Date of REC Opinion

  20 May 2024

• REC opinion

  Further Information Favourable Opinion