A Phase I/II Prospective, Randomized, Multicenter, Double-Masked, Vehicle-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Corneal Collagen Cross-Linking of Keratoprosthesis Carrier Tissue in High-Risk Keratoprosthesis Implantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 13
- 主要终点
- Time From Surgery to Device Loss or Replacement
研究概览
简要总结
This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.
详细描述
The study is a multi-center, parallel, randomized, double-blinded study with subsequent follow-up period of two years. Eight-four subjects across twelve sites will be randomized 1:1 to receive either a corneal tissue that have been cross-linked or not cross-linked (No UVA light source). Cross-linking is a term that refers to the linking of polymers (long chain) molecules by chemical bonds. It is believed that cross-linking the cornea will make the cornea stronger and more resistant to degradation.
CorneaGen (formerly Keralink International) (Baltimore site) will supply the donor tissue and Avedro Inc (Waltham MA) will supply the riboflavin and the UV light source. Staff at CorneaGenwill administer the riboflavin with dextran solution and perform the cross-linking procedure according to one of randomization groups before shipping the masked donor cornea to study sites for Boston Keratoprosthesis (B-KPro) implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent
- •Willing and able to comply with study assessments for the full duration of the study
- •Age ≥ 18 years
- •Candidate for a Boston Keratoprosthesis / Cornea transplant
- •In generally good stable overall health
- •Patients with an eye at risk for a cornea sterile ulcer which includes:
- •Autoimmune diseases (mucus membrane pemphigoid, Stevens-Johnson syndrome, systemic lupus erythematosis, rheumatoid arthritis, or other autoimmune diseases); OR
- •History of previous sterile cornea ulceration requiring a cornea transplant
排除标准
- •Age < 18 years
- •Inability to provide written informed consent and comply with study assessments for the full duration of the study
- •No or minimal tear production with evidence of keratinization of the bulbar conjunctiva
- •Corneal or ocular surface infection within 30 days prior to study entry
- •Ocular or periocular malignancy
- •Inability to wear a contact lens due to lid abnormalities or shortened fornix
- •Signs of current infection, including fever and current treatment with antibiotics
- •Pregnancy (positive pregnancy test) or lactating
- •Participation in another simultaneous interventional medical investigation or trial
研究组 & 干预措施
Active Treatment Arm
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
干预措施: Riboflavin (Drug)
Active Treatment Arm
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
干预措施: Dextran (Drug)
Active Treatment Arm
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
干预措施: UVA Light Source (Device)
Control Treatment Arm
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
干预措施: Riboflavin (Drug)
Control Treatment Arm
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
干预措施: Dextran (Drug)
结局指标
主要结局
Time From Surgery to Device Loss or Replacement
时间窗: 2 years
If the device fails after surgery the time and reason behind the failure will be recorded. The number of device losses in the control group will be compared to the number of device losses in investigational group.
次要结局
- Number of Participants With Kpro Retention at 12 Months(Twelve months)
- Number of Cumulative Delayed Epithelial Healing Events at Day 30(30 days)
- Median Time From Surgery to Retroprosthetic Membrane Treatment in Days (Laser or Surgical Interventions)(2 years)
- Median Time From Surgery to Occurrence of Vitritis (Sterile or Infectious)(2 years)
研究者
Joseph B. Ciolino, MD
Professor of Opthalmology
Massachusetts Eye and Ear Infirmary