A Pilot Study to Assess Safety and Efficacy of Intraoperative Topical Mitomycin C and Bevacizumab (Avastin) Applied to Bare Sclera in Pterygium Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Number of Participants Who Had Recurrence of Pterygia up to 1 Year
研究概览
简要总结
This study will evaluate the efficacy and safety of the use of bevacizumab (Avastin) as an adjunctive medication during pterygium surgery in preventing pterygium recurrence. A pterygium is a white fleshy growth on the surface of the eye, which can be removed surgically. However, after surgical removal, pterygia can recur. One way of minimizing recurrence is by applying a medication called mitomycin C to the surface of the eye during pterygium surgery. However, mitomycin is associated with certain side effects, such as thinning of the eye wall and poor wound healing. Bevacizumab has a different mechanism of action and there is some evidence that it may be useful in preventing pterygium recurrence. In this study, the safety and efficacy of adjunctive intraoperative use of bevacizumab and mitomycin C for preventing pterygium recurrence will be directly compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 80
- •Presence of primary or recurrent pterygium
- •Pterygium grows greater than 2mm onto cornea from limbus (using slit lamp light beam to measure size)
- •Pterygium is inducing astigmatism greater than 1 diopter compared to the fellow eye (to be determined by automated keratometry and manifest refraction)
- •The pterygium is symptomatic (irritation, inflammation, strabismus, decreased visual acuity)
排除标准
- •Age less than 18
- •Age greater than 80
- •Any systemic rheumatologic or autoimmune disorder (autoimmune hepatitis, bullous pemphigoid, celiac disease, Crohn's disease, dermatomyositis, Graves' disease, Hashimoto's thyroiditis, systemic lupus erythematosus, mixed connective tissue disease, pemphigus vulgaris, psoriasis, polymyositis, rheumatoid arthritis, scleroderma, Sjogren's disease, ulcerative colitis, vasculitis, Wegener's granulomatosus)
- •Women who are potentially child-bearing (no possibility of pregnancy for at least one month after surgery)
- •Any use within the past two months of topical eye drops other than artificial tears in the study eye
- •Any previous intravitreal injections of any medication in the study eye
- •Any previous use of systemic, topical, or intravitreal bevacizumab in either eye
- •Any history of subconjunctival injections in the study eye within the past year
- •Any history of scleral or corneal laceration in the study eye
- •Ocular surgery within the past 3 months in the study eye
- •History of scleral buckle placement in the study eye
- •History of glaucoma
研究组 & 干预措施
Bevacizumab
干预措施: Bevacizumab (Drug)
Mitomycin C
干预措施: Mitomycin C (Drug)
结局指标
主要结局
Number of Participants Who Had Recurrence of Pterygia up to 1 Year
时间窗: 1 year
次要结局
- Number of Participants Who Had Complications From the Time of Treatment to Recurrence(1 year)
- Number of Participants Who Had Related Serious Adverse Events From the Time of Treatment to 1 Year(1 year)
研究者
Nan Wang
Clinical Associate Professor - Ophthalmology
The University of Texas Health Science Center, Houston