Clinical Trial Results:
Multicenter clinical trial to evaluate the safety and feasibility of allogeneic tissue engineered product (human nanostructured artificial cornea) in patients with advanced corneal trophic ulcers refractory to (ophtalmic) conventional treatment.
Summary
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EudraCT number |
2010-024290-40 |
Trial protocol |
ES |
Global end of trial date |
15 Sep 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
06 Mar 2024
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First version publication date |
06 Mar 2024
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Other versions |
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Summary report(s) |
Final Report_Summary |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CAH/Ulc/2010
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Fundación Pública Andaluza Progreso y Salud M.P.
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Sponsor organisation address |
Avda. Américo Vespucio 15 · Edificio S-2 · 2ª Pta, Sevilla, Spain, 41092
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Public contact |
ROSARIO CARMEN MATA ALCÁZAR-CABALLERO, ROSARIO CARMEN MATA ALCÁZAR-CABALLERO, rosario.mata@juntadeandalucia.es
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Scientific contact |
ROSARIO CARMEN MATA ALCÁZAR-CABALLERO, ROSARIO CARMEN MATA ALCÁZAR-CABALLERO, rosario.mata@juntadeandalucia.es
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
10 Jan 2023
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
15 Sep 2022
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To evaluate the safety, feasibility and evidence of clinical efficacy of a model of human artificial nanostructured lamellar corneal, in patients with severe corneal disease for which there is currently no effective therapeutic.
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Protection of trial subjects |
The trial has been carried out in accordance with the recommendations for Clinical Trials and the evaluation of the product under investigation in humans, which appear in the Declaration of Helsinki,
revised in successive world assemblies (WMA, 2008), and the current Spanish Legislation on Clinical Trials. In addition, the ICH-GPC standards have been followed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Sep 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 15
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Worldwide total number of subjects |
15
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EEA total number of subjects |
15
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
15
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||
Pre-assignment
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Screening details |
- | |||||||||
Pre-assignment period milestones
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Number of subjects started |
15 | |||||||||
Number of subjects completed |
15 | |||||||||
Period 1
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Period 1 title |
Safety and feasibility (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1 | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Artificial cornea
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Implant
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Routes of administration |
Ocular use
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Dosage and administration details |
Not apply
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Arm title
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Group control | |||||||||
Arm description |
- | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Amniotic membrane transplant
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Matrix for implantation matrix
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Routes of administration |
Ocular use
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Dosage and administration details |
Not apply
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End points reporting groups
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Reporting group title |
Group 1
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Reporting group description |
- | ||
Reporting group title |
Group control
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Reporting group description |
- |
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End point title |
Safety and feasibility [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
During the study
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: It is detailed in the summary of the final clinical report |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From the inclusion of the first patient to the last visit of the last patient.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||
Dictionary version |
NA
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Frequency threshold for reporting non-serious adverse events: 1% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: It is detailed in the summary of the final clinical report |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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27 Aug 2013 |
Monitor change |
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29 Nov 2013 |
The calendar and expected completion date are updated |
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05 Mar 2014 |
The change of the person designated as Principal Investigator at the Hospital is communicated San Cecilio University of Granada |
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02 Feb 2016 |
New participating centers are added |
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27 Dec 2016 |
Inclusion criteria are modified |
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27 Mar 2018 |
For better management of services and development of tasks related to the clinical trial, various changes are made to the equipment researchers from the participating centers |
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02 May 2019 |
The main researcher at the Reina Sofia University Hospital changes
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10 Sep 2021 |
The principal investigator of the Costa del Sol hospital changes |
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24 Mar 2022 |
The person designated as Coordinating Investigator of the study is modified |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |