2023-506856-25-00招募中2 期
Phase IIb, randomised, controlled, unblinded, multicentre, clinical trial to evaluate the clinical efficacy of a nanostructured fibrin-agarose artificial cornea model (NANOULCOR) in patients with severe corneal ulcers.
Fundacion Publica Para La Investigacion Biosanitaria De Andalucia Oriental Alejandro Otero3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年11月13日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- 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
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •In order to be included in the study, patients must meet all the inclusion criteria described below:
- •Patients who give informed consent for participation in the study.
- •Presence of trophic corneal ulcers refractory to conventional medical treatment and secondary to one of the causes specified.
- •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...
- •There may be stromal involvement with a depth that does not reach Descemet's membrane. The location could be central or peripheral
- •Patients of both sexes over 18 years of age, with no upper age limit.
- •Duration of the disease causing the corneal ulcer equal to or longer than 3 weeks
- •Pregnancy blood test with negative result for patients of childbearing age.
- •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.
- •Willingness and ability to comply with the visit schedule, treatment plan, clinical analyses and all study procedures.
排除标准
- •Patients included in the study cannot meet any of the following exclusion criteria:
- •Corneal pathology that responds well to standard medical treatment within less than 3 weeks
- •Active ocular infection
- •Endothelial decompensation or bullous keratopathy
- •Visual acuity below light perception
- •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).
- •Pregnant or breastfeeding women.
- •History of active malignancy within the last 5 years
- •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.
结局指标
主要结局
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
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
次要结局
- 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
研究者
Elisa Mª Cubiles Montero de Espinosa
Scientific
Fundacion Publica Para La Investigacion Biosanitaria De Andalucia Oriental Alejandro Otero
研究点 (3)
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