Study of an artificial human tissue medicament for patients with severe corneal ulcers that not respond to conventional therapies.
EU CTIS ID: 2023-506856-25-00
What this study is testing
To determine the clinical efficacy of NANOULCOR in patients with severe corneal ulcers, compared to the control group, in terms of regeneration of the trophic defect.
- Therapeutic exploratory (Phase II)
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
- In order to be included in the study, patients must meet all the inclusion criteria described below: 1. Patients who give informed consent for participation in the study. 2. Presence of trophic corneal ulcers refractory to conventional medical treatment and secondary to one of the causes specified.3. Patients who, having previously suffered from this type of corneal ulcer, currently present sequelae of this pathology such as corneal thinning, corneal clouding, calcium keratopathy, etc... 4. There may be stromal involvement with a depth that does not reach Descemet's membrane. The location could be central or peripheral 5. Patients of both sexes over 18 years of age, with no upper age limit. 6. Duration of the disease causing the corneal ulcer equal to or longer than 3 weeks 7. Pregnancy blood test with negative result for patients of childbearing age. 8. Acceptance by the patient (both men and women) of childbearing age to use safe methods of birth control during the whole study, including the six-month follow-up. 9. Willingness and ability to comply with the visit schedule, treatment plan, clinical analyses and all study procedures.
You likely can't join if
- Patients included in the study cannot meet any of the following exclusion criteria: 1. Corneal pathology that responds well to standard medical treatment within less than 3 weeks 2. Active ocular infection 3. Endothelial decompensation or bullous keratopathy 4. Visual acuity below light perception 5. Positive serology for HBV, HCV, HIV or coexistence of any other pathology that, at the investigator's discretion, prevents the patient from continuing in the trial. In the case of HIV, it is understood that a positive serology implies a positive value for the anti-HIV antibody. In the case of HCV, a positive serology is defined as a positive anti-HCV antibody value. Finally, in the case of HBV, a positive serology is interpreted as a positive HBV antigen value or a positive viral load value (HBV-NAT). Inclusion of the subject will not be rejected if a positive anti-HBVc antibody is present and anti-HBVs immunization levels are sufficiently high to ensure adequate protection of the patient (anti-HBVs>100 IU/L). 6. Pregnant or breastfeeding women. 7. History of active malignancy within the last 5 years 8. Patients who have participated in the last 3 months prior to the inclusion of the study in a clinical trial. This period will be extended for clinical trials in advanced therapies, excluding from this trial those patients who have participated in the last 5 years in a clinical trial of 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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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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.