Retinal Detachment, Rhegmatogenous Retinal Detachment
Conditions
Keywords
vitrectomy surgery
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.
Interventions
Drug to be taken once daily for three days (two days prior to surgery and on the morning of surgery)
DRUGPlacebo
Dose to be taken once daily for three days (two days prior to surgery and on the morning of surgery)
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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. |
Countries
United States
Outcome results
None listed