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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06056596
Other study ID # 2022-1223
Secondary ID SMPH/OPHTHAL&VIS
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date January 30, 2024
Est. completion date August 2024

Study information

Verified date May 2024
Source University of Wisconsin, Madison
Contact Angie Adler
Phone 608-265-7557
Email amadler1@wisc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Lamivudine 300 MG
Drug to be taken once daily for three days (two days prior to surgery and on the morning of surgery)
Placebo
Dose to be taken once daily for three days (two days prior to surgery and on the morning of surgery)

Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma concentration of lamivudine after oral administration Mean concentration of lamivudine in plasma Pre-operative
Primary Intra-ocular concentration of lamivudine after oral administration Mean concentration of lamivudine in vitreous and aqueous humor Intra-operatively
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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