Lamivudine and Plasma Markers of Inflammation in Retinal Detachment

NCT06056596 | Terminated Early Phase 1 FDA Drug

• 3 other identifiers: 2022-1223SMPH/OPHTHAL&VIS SCI/FPRCProtocol Version 1/29/2024
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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).

Conditions

Retinal Detachment; Rhegmatogenous Retinal Detachment

Keywords

vitrectomy surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in erythrocyte sedimentation rate (millimeter per hour)

  Pre-operative to one week post-operative

• Change in C-reactive protein (milligrams per liter)

  Pre-operative to one week post-operative

• Change in concentration of inflammatory markers (picogram per milliliter)

  Pre-operative to one week post-operative

• Change in concentration of inflammatory markers (micrograms per milliliter)

  Pre-operative to one week post-operative

• Change in concentration of soluble IL-2 receptor alpha (Units per milliliter)

  Pre-operative to one week post-operative

Study Arms (2)

Lamivudine

EXPERIMENTAL

Lamivudine 300mg PO once daily for three days

Drug: Lamivudine 300 MG

Placebo

PLACEBO COMPARATOR

Placebo once daily for three days

Drug: Placebo

Interventions

Lamivudine 300 MG DRUG

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

Lamivudine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 or ≤ 75 years
• Patients with rhegmatogenous retinal detachment that require vitrectomy surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Retinal Detachment

Interventions

Lamivudine

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• Michael Altaweel, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: September 28, 2023
• Study Start: January 30, 2024
• Primary Completion: September 6, 2024
• Study Completion: September 6, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)