2024-515481-13-00招募中2 期
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 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月5日最近更新:
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 11
- 主要终点
- Incidence of adverse events and severe adverse events related with the IMP.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
次要结局
- 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).
研究者
Gloria Carmona Sánchez
Scientific
Red Andaluza De Diseno Y Traslacion De Terapias Avanzadas Fundacion Publica Andaluza Progreso Y Salud
研究点 (11)
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