First in human phase I/II clinical trial of RAFT for aniridia-related keratopathy

niversity College London0 个研究点目标入组 9 人开始时间: 2021年3月11日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•1. Confirmed diagnosis of congenital aniridia
•2. Confirmed diagnosis of advanced aniridia related keratopathy with corneal surface conjunctivalisation, vascularisation and increasing opacity with worsening vision loss, glare & ocular surface pain
•3. Patients aged 18 years and over
•4. Participants must use acceptable contraception from enrolment up to 6 weeks for female participants and 90 days for male participants, after stopping immunosuppression therapy
•5. Negative viral screen for, HIV, syphilis, hepatitis B & C and Human T-cell Leukaemia Virus (HTLV)
•6. Negative urine pregnancy test

•1. Poor tear production, as assessed by a Schirmer’s test type 1
•2. Lid malposition
•3. Current corneal infection
•4. Uncontrolled glaucoma (defined as uncontrolled eye pressure, changes to medication, recent surgery in the last 3 months or being considered for surgical treatment)
•5. Must not be NPL (no light perception) in one or both eyes
•6. Patients who refuse to consent to the site informing their GP of their participation
•7. Patients who lack capacity to give full informed consent to participate
•8. Pregnant or lactating women
•9. Patients with known contraindications to any of the following non-investigational medicinal products; mycophenolate, prednisolone, omeprazole, doxycycline, dexamethasone or moxifloxacin or excipients according to the relevant SmPCs
•10. Patients who are participating in any concurrent trial involving an investigational medical product, device or surgical intervention within the last 12 months
•11. Known albumin or egg allergy
•12. Known penicillin allergy
•13. Known hydrocortisone allergy
•14. Inability to lie flat for surgical procedure

发起方

niversity College London