Follow-up Study After ACLSCT for Restoration of Corneal Epithelium in Patients With LSCD Due to Ocular Burns (HOLOCORE-FU)
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|ClinicalTrials.gov Identifier: NCT03288844|
Recruitment Status : Recruiting
First Posted : September 20, 2017
Last Update Posted : August 3, 2020
|Condition or disease||Intervention/treatment|
|Limbal Stem Cell Deficiency Due to Ocular Burn||Procedure: Ophthalmologic examinations Other: Digital pictures Other: QoL Questionnaires|
HOLOCORE FOLLOW-UP prospective study offers the opportunity to collect long-term efficacy and safety data after one or two treatments with Holoclar. Moreover, since Holoclar (study drug used in the main HOLOCORE interventional clinical trial) is suspected to improve the success of keratoplasty in those patients candidate to receive this treatment but no data were collected in the three previous retrospective studies (HLSTM01, HLSTM02 and HLSTM04) on Holoclar, this follow-up study has been thought to observe the progress of the disease and to collect data on keratoplasty and evaluate the benefits of Holoclar in subsequent keratoplasty in patients treated once or two times with Holoclar.
All patients treated in the HOLOCORE clinical trial who consent to roll over to the present extension study at the end of the HOLOCORE will be observed for a follow-up period which may vary from a minimum of 12 month for the last patient to a maximum of 57 months for the first patient entered.
A total of approximately 70 patients is expected (all patients who completed the HOLOCORE study).
In case the last enrolled patient undergoes to Keratoplasty at the Last Visit of the Follow-up study, this will consequently lead to a prolongation of the study up to further 12 months for all patients.
The subjects will be enrolled and observed at the same investigational centers where they were recruited for the HOLOCORE clinical trial.
No drug will be administered for the scope of this study. Ophtalmological visits including pictures collection and quality of life evaluations will be performed every 6 months.
|Study Type :||Observational|
|Estimated Enrollment :||70 participants|
|Official Title:||Multinational, Multicenter, Prospective, Long-term Safety and Efficacy Follow-up Study After Autologous Cultivated Limbal Stem Cells Transplantation (ACLSCT) for Restoration of Corneal Epithelium in Patients With Limbal Stem Cell Deficiency Due to Ocular Burns|
|Actual Study Start Date :||December 13, 2017|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Patients who completed the main HOLOCORE clinical trial will undergo to Ophthalmologic examinations, Digital pictures collection and QoL questionnaires (NEI VFQ 25 and EQ-5D-3L/Y) will be performed/administered at each study visit
Procedure: Ophthalmologic examinations
epithelial defects assessment by fluorescein staining; superficial corneal neo-vascularization assessment; ocular tonometry; slit lamp examination; conjunctival (both bulbar and limbal) inflammation assessment; corneal sensitivity; central cornea involvement (for opacity or central CNV); Best-Corrected Visual Acuity; evaluation of symptoms.
Other: Digital pictures
Digital pictures 2D to be taken at each visit
Other: QoL Questionnaires
Quality of Life (NEI VFQ 25 and EQ-5D-3L/Y) questionnaires will be submitted at each visit
- Success of transplantation [ Time Frame: 1 year ]Transplantation will be considered with a clinically-relevant success if the severity of superficial corneal neo-vascularization will be judged as not exceeding one quadrant of invasion (without central cornea involvement) by the investigator and the degree of Epithelial defect as 'None' or 'Trace', respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288844
|Contact: Clinical Trials Info||+39 059 2058070||ClinicalTrialsemail@example.com|
|Hospital San Raffaele||Recruiting|
|Milan, Italy, 20100|
|Contact: Paolo Rama, MD|
|Study Director:||Graziella Pellegrini, Professor||Holostem Terapie Avanzate s.r.l.|
|Principal Investigator:||Paolo Rama, MD||San Raffaele Hospital|