Lamivudine and Plasma Markers of Inflammation in Retinal Detachment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Retinal Detachment, Rhegmatogenous Retinal Detachment

Intervention / Treatment
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* Drug: Lamivudine 300 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 or ≤ 65 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)) Current use of sorbitol or sorbitol-containing 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 Patients with a shallow anterior chamber or in whom anterior chamber paracentesis is considered unsafe

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lamivudine<br>Lamivudine 300mg PO once daily for three days | Drug: Lamivudine 300 MG<br>* Drug to be taken once daily for three days (two days prior to surgery and on the morning of surgery)<br>|
| Placebo Comparator: Placebo<br>Placebo once daily for three days | Drug: Placebo<br>* Dose to be taken once daily for three days (two days prior to surgery and on the morning of surgery)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of lamivudine after oral administration | Mean concentration of lamivudine in plasma | Pre-operative | 
| Intra-ocular concentration of lamivudine after oral administration | Mean concentration of lamivudine in vitreous and aqueous humor | Intra-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in erythrocyte sedimentation rate (millimeter per hour) | Mean concentration of inflammatory markers will in part be measured by erythrocyte sedimentation rate. | Pre-operative to one week post-operative | 
| Change in C-reactive protein (milligrams per liter) | Mean concentration of inflammatory markers will in part be measured by C-reactive protein. | Pre-operative to one week post-operative | 
| Change in concentration of inflammatory markers (picogram per milliliter) | 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. | Pre-operative to one week post-operative | 
| Change in concentration of inflammatory markers (micrograms per milliliter) | Mean concentration of inflammatory markers will in part be measured by interferon (IFN) alpha, IFN beta, IFN gamma in micrograms per milliliter) | Pre-operative to one week post-operative | 
| Change in concentration of soluble IL-2 receptor alpha (Units per milliliter) | Mean concentration of inflammatory markers will in part be measured by soluble IL-2 receptor alpha in Units per milliliter. | Pre-operative to one week post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitrectomy surgery