Lamivudine and Plasma Markers of Inflammation in Retinal Detachment

Retinal Detachment Clinical Trial

Official title:

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

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
• Start date: January 30, 2024
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: University of Wisconsin, Madison
• Contact: Angie Adler
• Phone: 608-265-7557
• Email: amadler1[@]wisc.edu
• Is FDA regulated: No
• 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 65 Years

Eligibility

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))
• 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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment
• Rhegmatogenous Retinal Detachment

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