Lamivudine and Plasma Markers of Inflammation in Retinal Detachment

Early Phase 1

Recruiting

• Conditions: Rhegmatogenous Retinal Detachment; Retinal Detachment
• Interventions: Drug: Lamivudine 300 MG; Drug: Placebo

• Registration Number: NCT06056596
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-28
• Study Start: 2024-01-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lamivudine	Lamivudine 300 MG	Lamivudine 300mg PO once daily for three days
Placebo	Placebo	Placebo once daily for three days

Primary Outcome Measures

Name	Time	Method
Plasma concentration of lamivudine after oral administration	Pre-operative	Mean concentration of lamivudine in plasma
Intra-ocular concentration of lamivudine after oral administration	Intra-operatively	Mean concentration of lamivudine in vitreous and aqueous humor

Secondary Outcome Measures

Name	Time	Method
Change in erythrocyte sedimentation rate (millimeter per hour)	Pre-operative to one week post-operative	Mean concentration of inflammatory markers will in part be measured by erythrocyte sedimentation rate.
Change in C-reactive protein (milligrams per liter)	Pre-operative to one week post-operative	Mean concentration of inflammatory markers will in part be measured by C-reactive protein.
Change in concentration of inflammatory markers (picogram per milliliter)	Pre-operative to one week post-operative	Mean concentration of inflammatory markers will in part be measured by tumor necrosis factor alpha, interleukin (IL)-18, IL-1 beta, IL-6, IL-10, MCP-1, MIP-1 alpha, GM-CSF in picograms per milliliter.
Change in concentration of inflammatory markers (micrograms per milliliter)	Pre-operative to one week post-operative	Mean concentration of inflammatory markers will in part be measured by interferon (IFN) alpha, IFN beta, IFN gamma in micrograms per milliliter)
Change in concentration of soluble IL-2 receptor alpha (Units per milliliter)	Pre-operative to one week post-operative	Mean concentration of inflammatory markers will in part be measured by soluble IL-2 receptor alpha in Units per milliliter.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States