Back to resultsLamivudine and Plasma Markers of Inflammation in Retinal Detachment
Primary Purpose
Retinal Detachment, Rhegmatogenous Retinal Detachment
Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lamivudine 300 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Detachment focused on measuring vitrectomy surgery
Eligibility Criteria
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)) Current use of sorbitol or sorbitol-containing 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 Patients with a shallow anterior chamber or in whom anterior chamber paracentesis is considered unsafe
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lamivudine
Placebo
Arm Description
Lamivudine 300mg PO once daily for three days
Placebo once daily for three days
Outcomes
Primary Outcome Measures
Plasma concentration of lamivudine after oral administration
Mean concentration of lamivudine in plasma
Intra-ocular concentration of lamivudine after oral administration
Mean concentration of lamivudine in vitreous and aqueous humor
Secondary Outcome Measures
Change in erythrocyte sedimentation rate (millimeter per hour)
Mean concentration of inflammatory markers will in part be measured by erythrocyte sedimentation rate.
Change in C-reactive protein (milligrams per liter)
Mean concentration of inflammatory markers will in part be measured by C-reactive protein.
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.
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)
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.
Full Information
NCT ID
NCT06056596
First Posted
August 1, 2023
Last Updated
September 20, 2023
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT06056596
Brief Title
Lamivudine and Plasma Markers of Inflammation in Retinal Detachment
Official Title
Intra-ocular Penetration of Oral Lamivudine and Measurement of Systemic Inflammatory Markers in Patients Undergoing Rhegmatogenous Retinal Detachment Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Detachment, Rhegmatogenous Retinal Detachment
Keywords
vitrectomy surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lamivudine
Arm Type
Experimental
Arm Description
Lamivudine 300mg PO once daily for three days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo once daily for three days
Intervention Type
Drug
Intervention Name(s)
Lamivudine 300 MG
Intervention Description
Drug to be taken once daily for three days (two days prior to surgery and on the morning of surgery)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Dose to be taken once daily for three days (two days prior to surgery and on the morning of surgery)
Primary Outcome Measure Information:
Title
Plasma concentration of lamivudine after oral administration
Description
Mean concentration of lamivudine in plasma
Time Frame
Pre-operative
Title
Intra-ocular concentration of lamivudine after oral administration
Description
Mean concentration of lamivudine in vitreous and aqueous humor
Time Frame
Intra-operatively
Secondary Outcome Measure Information:
Title
Change in erythrocyte sedimentation rate (millimeter per hour)
Description
Mean concentration of inflammatory markers will in part be measured by erythrocyte sedimentation rate.
Time Frame
Pre-operative to one week post-operative
Title
Change in C-reactive protein (milligrams per liter)
Description
Mean concentration of inflammatory markers will in part be measured by C-reactive protein.
Time Frame
Pre-operative to one week post-operative
Title
Change in concentration of inflammatory markers (picogram per milliliter)
Description
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.
Time Frame
Pre-operative to one week post-operative
Title
Change in concentration of inflammatory markers (micrograms per milliliter)
Description
Mean concentration of inflammatory markers will in part be measured by interferon (IFN) alpha, IFN beta, IFN gamma in micrograms per milliliter)
Time Frame
Pre-operative to one week post-operative
Title
Change in concentration of soluble IL-2 receptor alpha (Units per milliliter)
Description
Mean concentration of inflammatory markers will in part be measured by soluble IL-2 receptor alpha in Units per milliliter.
Time Frame
Pre-operative to one week post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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))
Current use of sorbitol or sorbitol-containing 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
Patients with a shallow anterior chamber or in whom anterior chamber paracentesis is considered unsafe
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angie Adler
Phone
608-265-7557
Email
amadler1@wisc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Altaweel, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angie Adler
Phone
608-265-7557
Email
amadler1@wisc.edu
First Name & Middle Initial & Last Name & Degree
Michael Altaweel, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Lamivudine and Plasma Markers of Inflammation in Retinal Detachment
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