Sequelae of Previous Trophic Corneal Ulcers Clinical Trial
Official title:
Multicenter Clinical Trial to Evaluate the Safety and Feasibility of an Allogeneic Tissue Engineered Drug (Nanostructured Artificial Human Cornea) in Patients With Corneal Trophic Ulcers Refractory to Conventional Treatment
| Verified date | January 2021 |
| Source | Andalusian Network for Design and Translation of Advanced Therapies |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a prospective, phase I-II, randomised, open-label clinical trial that will evaluate the safety and feasibility, as well as clinical efficacy evidence, of a bioengineered anterior corneal substitute in adults with severe trophic corneal ulcers. This model of human anterior allogeneic cornea will provide an alternative approach in cases where human donor keratoplasty is not an option.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | January 14, 2021 |
| Est. primary completion date | January 14, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Man or woman aged=18, with no upper age limit. - Patients that give their informed consent for study participation. - Stage 3 Mackie corneal ulcers that do not respond to conventional medical treatment, or patients having undergone previous stage 3 Mackie corneal ulcers,33 currently suffering sequelae such as stromal fibrosis or corneal thinning, having no effective therapeutic alternative. - Stromal involvement, not reaching the Descemet membrane. Central or peripheral localization. - Minimum duration of the disease causing the corneal ulcer: 6 weeks. - No active ocular infection. - Patients with normal laboratory parameters as defined by: Leukocytes=3000 cells/µL; Neutrophils=1500 cells/µL; Platelets=100 billion/L; AST/ALT=1.5 ULN; Creatinine=1.5 mg/dL. Exclusion Criteria: - Absence of stromal involvement. - Good response to standard medical treatments for corneal disease in less than 3 to 5 weeks. - Bullous keratopathy or other endothelial decompensations. - Active ocular infection. - Positive serology to HBV, HCV, HIV or any other pathology that may interfere with correct patient follow-up. - Pregnant or breast-feeding women or childbearing-age women that do not consent the use of contraceptive methods approved in the protocol. - Medical history of active neoplasia within the past 5 years. Participation in other clinical trials in 3 months previous to inclusion, or in the previous 5 years for trials with advanced therapies. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital San Juan de Dios | Bormujos | |
| Spain | University Hospital Puerta del Mar | Cádiz | |
| Spain | Hospital la Arruzafa | Córdoba | |
| Spain | Hospital Universitario Reina Sofía | Córdoba | |
| Spain | University Hospital San Cecilio | Granada | |
| Spain | University Hospital Virgen de las Nieves | Granada | |
| Spain | Marina Rodriguez Calvo-Mora | Málaga | |
| Spain | Hospital Costa del Sol | Marbella | |
| Spain | Hospital Nuestra Señora de Valme | Sevilla | |
| Spain | University Hospital Virgen de Rocío | Sevilla | |
| Spain | University Hospital Virgen Macarena | Sevilla |
| Lead Sponsor | Collaborator |
|---|---|
| Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud | Iniciativa Andaluza en Terapias Avanzadas |
Spain,
González-Andrades M, Mata R, González-Gallardo MDC, Medialdea S, Arias-Santiago S, Martínez-Atienza J, Ruiz-García A, Pérez-Fajardo L, Lizana-Moreno A, Garzón I, Campos A, Alaminos M, Carmona G, Cuende N. A study protocol for a multicentre randomised clinical trial evaluating the safety and feasibility of a bioengineered human allogeneic nanostructured anterior cornea in patients with advanced corneal trophic ulcers refractory to conventional treatment. BMJ Open. 2017 Sep 24;7(9):e016487. doi: 10.1136/bmjopen-2017-016487. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Adverse events (and serious adverse events) causally related to experimental treatment. | 24 months | ||
| Primary | Implant status (integrity, detachment and reabsorption) | 24 months | ||
| Primary | Local, regional or systemic infections related with the implant | 24 months | ||
| Primary | Induced corneal neovascularization | 24 months | ||
| Secondary | Ulcer persistency or relapse and corneal stromal repair | 24 months | ||
| Secondary | Visual acuity | 24 months | ||
| Secondary | Corneal transparency | 24 months | ||
| Secondary | Tear function (TBUT and Schirmer) | 24 months | ||
| Secondary | Quality of life (EQ-5) | 24 months | ||
| Secondary | Induced chronic ocular complications | 24 months | ||
| Secondary | In vivo confocal microscopy (IVCM) analysis of the grafted bioengineered cornea (and AM) | 24 months |