A clinical study to follow up the implantation of Holoclar on the cornea of patients with ocular burns
- Conditions
- corneal lesions with associated moderate to severe limbal stem cell deficiency due to ocular burnsMedDRA version: 20.0 Level: LLT Classification code 10011012 Term: Corneal epithelium opacity System Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2015-001344-11-NL
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 70
All patients (adults and pediatrics) who completed the HOLOCORE
core study and who consent to roll over to the present extension
study at the end of the HOLOCORE follow-up.
Are the trial subjects under 18? yes
Number of subjects for this age range: 5
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 11
No specific exclusion criterion is considered for this study, except for
patients dropping out from the HOLOCORE study or withdrawing
consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method