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Allogeneic Tissue Engineering (Nanostructured Artificial Human Cornea) in Patients With Corneal Trophic Ulcers in Advanced Stages, Refractory to Conventional (Ophthalmic) Treatment.
EU CTIS ID: 2024-515481-13-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.