2024-515481-13-00
Not yet recruiting
Phase 1/2
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.
Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud11 sites in 1 country20 target enrollmentStarted: July 5, 2024Last updated:
Overview
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud
- Enrollment
- 20
- Locations
- 11
- Primary Endpoint
- Incidence of adverse events and severe adverse events related with the IMP.
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients that give their informed consent for study participation.
- •Stage 3 Mackie corneal ulcers that do not respond to conventional medical treatment, and may also be secondary to any of the following causes: Riley-Day syndrome (familial dysautonomia), Goldenhar-Gorlin syndrome, Mobius syndrome, Corneal hypoesthesia family, Diabetes, Multiple sclerosis, Leprosy, Hypovitaminosis A, Autoimmune disorders, Acoustic neuroma, Meningioma, Neuralgia, Aneurysm, Stroke, Neoplasia, Herpes simplex, Herpes zoster, Caustication, Wound, inflammation, or wearing contact lenses, Cataract surgery or keratoplasty (aggression to ciliary nerves), Abuse of topical anesthetics, Toxicity of timolol, betaxolol, diclofenac sodium or sulfacetamide, Lattice or granular, Orbital neoplasia.
- •Patients having undergone previous stage 3 Mackie corneal ulcers, 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.
- •No active ocular infection.
- •Man or woman aged ≥18, with no upper age limit.
- •Minimum duration of the disease causing the corneal ulcer: 6 weeks.
- •Patients with normal laboratory parameters as defined by: Leukocytes ≥ 3000, Neutrophils ≥ 1500, Platelets ≥ 100000, 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.
- •Active ocular infection.
- •Bullous keratopathy or other endothelial decompensations.
- •Positive serology to HBV, HCV, HIV or any other pathology that may interfere with correct patient follow-up. In the case of HIV, it is understood that a positive serology implies a positive value in the anti-HIV antibody. In the case of HCV, a serology is considered positive when a positive value is obtained for the anti-HCV antibody. Finally, in the case of HBV, positive serology is interpreted as a positive HBV-antigen value or a positive viral load value (HBV-NAT). The inclusion of the subject will not be ruled out if a positive anti-HBVc core antibody is present and the anti-HBVs immunization levels are high enough to guarantee adequate protection of the patient (anti-HBVs > 100 IU/L).
- •Pregnant or breast-feeding women or childbearing-age women that do not consent the use of contraceptive methods approved in the protocol. Hormonal contraceptive methods that inhibit ovulation (combining estrogens with progestogens or progestogens only) for oral, transdermal, intravaginal, injectable or implantable administration, IUD, surgical sterilization or total abstinence are described as an effective contraceptive method.
- •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.
Outcomes
Primary Outcomes
Incidence of adverse events and severe adverse events related with the IMP.
Incidence of adverse events and severe adverse events related with the IMP.
Graft conditions (artificial cornea): integrity, graft survival or reabsorption.
Graft conditions (artificial cornea): integrity, graft survival or reabsorption.
Local, regional or systemic infection signs.
Local, regional or systemic infection signs.
Induced corneal vascularization.
Induced corneal vascularization.
Secondary Outcomes
- Ulcer persistence or regeneration of corneal stroma.
- Visual acuity.
- Corneal transparency.
- Quality of life (EQ5, part I and II).
- Characterization of corneal surface (impression citology & OCT mapping).
Investigators
Gloria Carmona Sánchez
Scientific
Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud
Study Sites (11)
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