Intra-ocular Penetration of Oral Lamivudine and Measurement of Systemic Inflammatory Markers in Patients Undergoing Rhegmatogenous Retinal Detachment Surgery

2022-1223

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).

2024-01-30

2024-08-01

2024-08-01

Recruiting

Early phase I

20

Inclusion Criteria: * Age ≥ 18 or ≤ 75 years * Patients with rhegmatogenous retinal detachment that require vitrectomy surgery Exclusion Criteria: * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-05-16