Study of an artificial human tissue medicament for patients with severe corneal ulcers that not respond to conventional therapies.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacion Publica Para La Investigacion Biosanitaria De Andalucia Oriental Alejandro Otero

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

12 Mar 2025 → ongoing

Decision date (initial)

2023-11-13

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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.

Secondary objectives 1

1. Effectiveness: Reduction of the time to healing; Improvement of visual acuity; Reduction of corneal complications according to the SOTOZONE scale; Improvement of the patient's quality of life. Security: To ratify the safety data of NANOULCOR, already demonstrated in the previous trial. Feasibility: To ratify the feasibility data of NANOULCOR, already demonstrated in the previous trial, to ensure its clinical implementation in the healthcare system.

Conditions and MedDRA coding

Corneal ulcer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 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.

Exclusion criteria 1

1. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The main efficacy variable will be the capacity of NANOULCOR to regenerate the trophic defect, compared to the control group. For this purpose, the difference between the two treatment groups will be assessed in the percentage of patients in whom the epithelial defect disappears. The status of the trophic defect will be assessed at all visits

Secondary endpoints 1

1. Effectiveness Time to healing, Changes in visual acuity, Incidence of corneal complications according to the SOTOZONE scale, Changes in the patient's quality of life. Security Occurrence of AE and SAE. Status of the implanted corneal construct: maintenance of its integrity, detachment or resorption. Feasibility The percentage of patients in whom treatment with NANOULCOR has been feasible shall be recorded, including all points in the process

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacion Publica Para La Investigacion Biosanitaria De Andalucia Oriental Alejandro Otero

Sponsor organisation

Fundacion Publica Para La Investigacion Biosanitaria De Andalucia Oriental Alejandro Otero

Address

Pab De Consultas Externas Floor 2, Avenida De Madrid 2 Avenida De Madrid 2

City

Granada

Postcode

18012

Country

Spain

Scientific contact point

Organisation

Fundacion Publica Para La Investigacion Biosanitaria De Andalucia Oriental Alejandro Otero

Contact name

Elisa Mª Cubiles Montero de Espinosa

Public contact point

Organisation

Fundacion Publica Para La Investigacion Biosanitaria De Andalucia Oriental Alejandro Otero

Contact name

Elisa Mª Cubiles Montero de Espinosa

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 21 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications