Long-term safety after Holoclar® implant for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns: observational study of routine clinical practice (HOLOSIGHT)

Study identification

• EU PAS number:
  EUPAS10043
• Study ID:
  36923
• Official title and acronym:
  Long-term safety after Holoclar® implant for restoration of corneal epithelium in patients with limbal stem cell deficiency due to ocular burns: observational study of routine clinical practice (HOLOSIGHT)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  Belgium

  Czechia

  Denmark

  France

  Germany

  Italy

  Netherlands

  United Kingdom
• Study description:
  This observational, prospective, study aims to evaluate the long-term safety profile of patients treated with Holoclar® during a 5-year follow-up period from first ocular implantation under routine clinical conditions, through the description of the occurrence of adverse events, adverse drug reactions, serious adverse events and adverse events of special interest.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Holostem Terapie Avanzate Srl

Study timelines

Date when funding contract was signed

Planned: 05/05/2015

Actual: 05/05/2015

Study start date

Planned: 20/09/2016

Actual: 20/10/2016

Data analysis start date

Planned: 01/03/2027

Date of final study report

Planned: 31/12/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Holostem Terapie Avanzate Srl

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)