Intra-ocular Penetration of Oral Lamivudine and Measurement of Systemic Inflammatory Markers in Patients Undergoing Rhegmatogenous Retinal Detachment Surgery
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Plasma concentration of lamivudine after oral administration
研究概览
简要总结
The goal of this clinical trial is to test whether an oral medication (lamivudine) enters the eye and reduces blood markers of inflammation in people who undergo retinal detachment surgery (pars plana vitrectomy).
Participants will take the study medication or placebo, and the researchers will measure blood markers of inflammation before and after surgery. The researchers will also measure the amount of medication in the blood and fluid inside the participant's eye (which is collected during surgery).
详细描述
Lamivudine is an anti-viral medication that has intrinsic anti-inflammatory properties that could be useful in the treatment of vitreoretinal disease. It is not known whether lamivudine enters the eye after oral administration. The purpose of this study is to measure the intra-ocular concentration of lamivudine after oral administration in participants that require pars plana vitrectomy surgery for repair of rhegmatogenous retinal detachment. Participants undergoing retinal detachment surgery will receive oral lamivudine for three days prior to surgery; lamivudine will be measured intra-operatively (vitreous and aqueous humor) and pre-operatively (plasma). Plasma markers of inflammation will be measured before and after surgery.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 or ≤ 75 years
- •Patients with rhegmatogenous retinal detachment that require vitrectomy surgery
排除标准
- •Previous pars plana vitrectomy in the affected eye
- •Positive for Hepatitis B surface antigen or HIV antibodies, or history of Hepatitis B/HIV
- •Pregnant or breast-feeding
- •Liver disease or abnormal AST/ALT
- •Renal impairment (Creatinine clearance < 50)
- •Diabetes with current use of insulin
- •Anemia (Hemoglobin <13.2 g/dL (male) or < 11.6 g/dL (female))
- •Unwilling to hold concurrent use of sorbitol or sorbitol-containing medications or products while taking study medication(including, but not limited to: blackberries, raspberries, strawberries, stone fruits, apples, avocados, sugar-free items such as chewing gum, hard candies, snack bars, frozen desserts, and chocolates, liquid and capsule/caplet analgesics, cough/cold/flu syrup, liquid and capsule/caplet pseudoephedrine, chewable antacid tablets, liquid and capsule allergy medications, motion sickness and nausea medications)
- •Current use of trimethoprim-sulfamethoxazole
- •Pancreatitis or history of pancreatitis
- •Uncontrolled blood pressure (> 160 mm Hg systolic or >100 mm Hg diastolic) within the last 3 months, or current use of more than one anti-hypertensive medication
- •History of stroke, myocardial infarction, or congestive heart failure
- •Current vitreous hemorrhage that obscures view of retinal details
- •Patients with a shallow anterior chamber or in whom anterior chamber paracentesis is considered unsafe
研究组 & 干预措施
Lamivudine
Lamivudine 300mg PO once daily for three days
干预措施: Lamivudine 300 MG (Drug)
Placebo
Placebo once daily for three days
干预措施: Placebo (Drug)
结局指标
主要结局
Plasma concentration of lamivudine after oral administration
时间窗: Pre-operative
Mean concentration of lamivudine in plasma
Intra-ocular concentration of lamivudine after oral administration
时间窗: Intra-operatively
Mean concentration of lamivudine in vitreous and aqueous humor
次要结局
- Change in erythrocyte sedimentation rate (millimeter per hour)(Pre-operative to one week post-operative)
- Change in C-reactive protein (milligrams per liter)(Pre-operative to one week post-operative)
- Change in concentration of inflammatory markers (picogram per milliliter)(Pre-operative to one week post-operative)
- Change in concentration of inflammatory markers (micrograms per milliliter)(Pre-operative to one week post-operative)
- Change in concentration of soluble IL-2 receptor alpha (Units per milliliter)(Pre-operative to one week post-operative)