Clinical Trials Logo
  1. Home
  2. Aniridia
  3. NCT05044598

RAFT - Clinical Trial of RAFT for Aniridia Related Keratopathy — RAFT  

Aniridia Clinical Trial

Official title:
RAFT - First in Human Phase I/II Clinical Trial of RAFT for Aniridia Related Keratopathy

Clinical Trial Summary

The RAFT trial is a first in human trial of a novel cellular therapy called RAFT-OS (Real Architecture for 3D Tissues Ocular Surface) developed and manufactured by Cells for Sight Stem Cell Therapy Research Unit at UCL institute of Ophthalmology. The aim of this seamless phase I/II single-dose, single-arm trial is to investigate if RAFT-OS is a safe and effective alternative treatment for patients with aniridia related keratopathy (ARK) in 21 patients. ARK is a complication of aniridia, which is a genetic eye condition present from birth. RAFT-OS is an artificial tissue, populated with limbal epithelial cells and stromal cells. The source of the adult limbal and stromal cells is from donated human corneas from the NHS blood and Transplant, Tissue and Eye services in Liverpool. Following a Screening visit, participants will commence 10-weeks of immune suppression therapy to prepare for the transplantation of RAFT-OS. The RAFT-OS will be transplanted into the participants worst affected eye. Following surgery, each participant will be assessed at days 1, 7, 14, 21, and 1-month for major or intermediate safety events. Participants will continue to be followed up to 12 months after transplantation and will be required to stay on the immune suppression therapy for the duration of the trial. The trial is conducted at Moorfields Eye Hospital NHS Foundation Trust (MEH), London in the United Kingdom (UK). MEH is a leading provider of eye health services in the UK and is a world-class centre of excellence for ophthalmic research and education. All trial medical assessments and procedures will be performed in an appropriate clinical setting by suitability qualified staff.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05044598
Study type Interventional
Source University College, London
Contact Amalia Ndoutoumou
Phone 020 3108 9840
Email raft@ucl.ac.uk
Status Recruiting
Phase Phase 1/Phase 2
Start date July 28, 2021
Completion date May 31, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT00758108 - Characterization of WAGR Syndrome and Other Chromosome 11 Gene Deletions
Recruiting NCT05400590 - Comparison of the Healing Properties on Corneal Cells of Groth Factor-enriched Plasma and Autologous Serum From Aniridia Patients
Recruiting NCT01793168 - Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Completed NCT00001161 - Abnormalities of the Eye's Anterior Chamber, Iris, Cornea and Lens N/A
Enrolling by invitation NCT03461978 - Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures N/A
Recruiting NCT05954403 - National Cohort on Congenital Defects of the Eye
Completed NCT02647359 - Study of Ataluren in Participants With Nonsense Mutation Aniridia Phase 2
Completed NCT03581864 - Clinical Outcomes of Implantationof Black Diaphragm Intraocular Lens in Complete Aniridia and Aphakia Due to Posttraumatic Eye Rupture
Recruiting NCT05562115 - Proteomic Study of Tears From Patients With a PAX6 Mutation N/A
Completed NCT00265590 - Correlation of Gene Abnormalities and Clinical Manifestations of Aniridia N/A
Withdrawn NCT04117880 - A Phase 2 Open Label Extension Study in Participants With Nonsense Mutation Aniridia Phase 2
Active, not recruiting NCT00503893 - Genetics of Wilms' Tumor and/or the Associated Conditions of Aniridia, Hemihypertrophy, and Genitourinary Anomalies
Completed NCT01644552 - Positive Angle Kappa
Completed NCT00812708 - Clinical Evaluation of Morcher Artificial Iris Diaphragms N/A