Clinical Research Units
Clinical Trials Unit
The IOBA has participated in more than 60 clinical trials with medicines, medical devices and advanced therapies in ophthalmology to date, in addition to numerous prospective observational studies.
In addition, it has been an important part in the achievement of independent, non-profit research clinical trials in advanced therapies and retinal diseases.
Given the relevance of this type of study and the control necessary to carry it out, in 2005 the Clinical Trials Unit was created to provide direct support to the researchers of the center and the institution.
The unit is in charge of the relations between the research teams and the patients of each project, but also of the external relations with the health authorities, ethical committees for drug research, promoters of clinical trials and contract research companies.
To facilitate the carrying out of this type of project, the IOBA has the necessary infrastructure, equipment and personnel for the successful completion of clinical trials in the area of vision sciences, as required by the Standards of good clinical practice.
The institute has specific examination rooms and certified rooms, as well as spaces for filing and monitoring tests.
Mixed unit «University Clinical Hospital – IOBA»
Aware of the need to join efforts, an agreement was signed in 2015, currently in force and renewed annually, for the creation of a mixed unit that promotes clinical trials and clinical studies in ophthalmology and vision sciences under the umbrella of the Specific agreement signed between the University of Valladolid and the regional management of Sacyl.
Through this agreement, the EECCs are evaluated by the Research Ethics Committee. The recruitment of patients in both institutions is authorized and the possibility of sharing technical means and specific personnel, when required.
Controlled Environment Laboratory (CELab; Controlled Environment Laboratory)
For clinical trials, the IOBA has access to the CELab, a controlled environment chamber that allows to control the conditions of pressure, humidity, temperature, lighting and air flow and whose use presents the following potential benefits:
– Greater reliability of the results of diagnostic tests with the need for a smaller number of subjects.
– Realization and analysis of a large number of evaluation tests and biomarkers.
– Previous selection of the evaluation variables for subsequent multicenter clinical trials.
– Possibility of obtaining a «yes/no» response before performing a large sample of patients for multicenter clinical trials.
– Increases speed and saves economic resources in drug development, registration and marketing programs.
Cellular therapy
Several clinical trials of this type have been carried out at the IOBA in the following pathologies:
– Deficiency of corneolimbar stem cells, treated with limbal epithelial stem cells (autologous or allogeneic).
– Deficiency of corneolimbar stem cells, treated with allogeneic bone marrow mesenchymal stem cells.
– Non-arteritic Acute Ischemic Optic Neuropathy (NAION), treated with allogeneic bone marrow mesenchymal stem cells.
Profesionals
Ana Rodríguez Andrés
Gestión Económica. Coordinadora de Administración Investigación y Formación.
Dr. Agustín Mayo Íscar
Doctor en Estadística
Dra. Maribel López Gálvez
Especialista en Oftalmología - Responsable Unidad Mixta HCUV-IOBA
Dra. Marina López Paniagua
Gestora de Proyectos de Terapia Celular - Doctora en Ciencias de la Visión
Esther Murgui Tejedor
Coordinadora de Estudio - Unidad de Ensayos Clínicos
Francisco Blázquez Araúzo
Responsable Médico - Unidad de Ensayos Clínicos
Laura Sanz Blanco
Personal de administración del Centro de Lectura de Retinografías
Marian Quevedo Gallego
Coordinadora de Estudios
