Lamivudine and Plasma Markers of Inflammation in Retinal Detachment

NCT ID: NCT06056596

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-30
• Study Completion Date: 2024-09-06

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.

Conditions

Retinal Detachment; Rhegmatogenous Retinal Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lamivudine

Lamivudine 300mg PO once daily for three days

Group Type: EXPERIMENTAL

Lamivudine 300 MG

Intervention Type: DRUG

Drug to be taken once daily for three days (two days prior to surgery and on the morning of surgery)

Placebo

Placebo once daily for three days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dose to be taken once daily for three days (two days prior to surgery and on the morning of surgery)

Interventions

Lamivudine 300 MG

Drug to be taken once daily for three days (two days prior to surgery and on the morning of surgery)

Intervention Type: DRUG

Placebo

Dose to be taken once daily for three days (two days prior to surgery and on the morning of surgery)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Altaweel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

SMPH/OPHTHAL&VIS SCI/FPRC

Identifier Type: OTHER

Identifier Source: secondary_id

Protocol Version 1/29/2024

Identifier Type: OTHER

Identifier Source: secondary_id

2022-1223

Identifier Type: -

Identifier Source: org_study_id