CTRI/2026/01/100616尚未招募3 期
A multi-center, open-label, single-arm study to assess the safety and efficacy of collagen ophthalmic matrix for anterior lamellar keratoplasty.
ACRO Biomedical Co Ltd11 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年1月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- Incidence of irreversible graft dissociation melting or rejection up to 6 months Adverse events TEAE
研究概览
简要总结
This is a multi-centre, open-label, single-arm phase III clinical study evaluating the safety, efficacy and acceptability of ABCcolla® Collagen Ophthalmic Matrix in patients with non-healing corneal ulcers undergoing lamellar keratoplasty. The study involves 150 patients across India, with a follow-up of 24 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female aged 20 to 60 years Patient who has been diagnosed with corneal ulcer due to bacterial, fungal or parasite infection not responding to medical treatment for one to two weeks for bacterial or fungal keratitis and a minimum of one month for parasitic infection; exposure to chemical burns classified as Grade III or IV; or severe trauma not responding to medical treatment The corneal ulcer affects corneal stroma depth to more than one third and less than two thirds of the stroma and infiltrate more than three millimeters and less than ten millimeters in diameter, detected by Optical Coherence Tomography Best Corrected Visual Acuity of less than 0.05 as measured on the logMAR chart, equivalent to Snellen notation 20 over 400 in feet or 6 over 120 in meters Patient or impartial witness who signs the informed consent form and agrees to complete the treatment and follow-up Patients who are not responsive to treatment for one to two weeks for bacterial or fungal keratitis and a minimum of one month for parasitic infection.
排除标准
- •Treated with keratoplasty before Has a corneal ulcer smaller than 3 mm or larger than 10 mm in diameter Has corneal ulcer infiltrates less than one third or more than two thirds in depth Has severe dry eye disease as assessed by Schirmers Test II less than 5 mm Has cataracts on the eyes Experiences incomplete eyelid closure Has liver function ALT and AST tests with the score as two fold or greater than that of the normal Has renal function creatinine Cr level greater than two fold of the normal Has serum albumin level lower than 10 percent of normal value Has severe cardiovascular and cerebral vascular disease Has diabetes Has a malignant or benign tumor Known to be allergic to collagen Has a systemic collagen connective tissue disease Has allergic reactions to porcine tissue Use of anticoagulants five days before screening Use of topical oral or injectable NSAIDs three days before screening The patient does not accept porcine tissue for any reason Pregnant or breastfeeding women or childbearing age women who plan to get pregnant Participates in other drug or medical instrument clinical trials in the last 12 weeks Not being considered suitable for this study by the principal investigator Has glaucoma Cases with defective limbus or cornea without limbus or severe injury to limbus.
结局指标
主要结局
Incidence of irreversible graft dissociation melting or rejection up to 6 months Adverse events TEAE
时间窗: Up to 6 months 24 weeks post implantation.
次要结局
- Graft transparency(Neovascularization)
研究者
Dr Siddhartha Patil
Raptim Research Pvt. Ltd
研究点 (11)
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