Lamivudine and Plasma Markers of Inflammation in Retinal Detachment

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06056596

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Retinal Detachment Rhegmatogenous Retinal Detachment	Drug: Lamivudine 300 MG Drug: Placebo	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2024

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lamivudine Lamivudine 300mg PO once daily for three days	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 Comparator: Placebo Placebo once daily for three days	Drug: Placebo Dose to be taken once daily for three days (two days prior to surgery and on the morning of surgery)

Arm

Intervention/Treatment

Experimental: Lamivudine

Lamivudine 300mg PO once daily for three days

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 Comparator: Placebo

Placebo once daily for three days

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

Plasma concentration of lamivudine after oral administration [Pre-operative]
Mean concentration of lamivudine in plasma
Intra-ocular concentration of lamivudine after oral administration [Intra-operatively]
Mean concentration of lamivudine in vitreous and aqueous humor

Secondary Outcome Measures

Change in erythrocyte sedimentation rate (millimeter per hour) [Pre-operative to one week post-operative]
Mean concentration of inflammatory markers will in part be measured by erythrocyte sedimentation rate.
Change in C-reactive protein (milligrams per liter) [Pre-operative to one week post-operative]
Mean concentration of inflammatory markers will in part be measured by C-reactive protein.
Change in concentration of inflammatory markers (picogram per milliliter) [Pre-operative to one week post-operative]
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) [Pre-operative to one week post-operative]
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) [Pre-operative to one week post-operative]
Mean concentration of inflammatory markers will in part be measured by soluble IL-2 receptor alpha in Units per milliliter.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin	Madison	Wisconsin	United States	53705

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator: Michael Altaweel, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT06056596

Other Study ID Numbers:

2022-1223
SMPH/OPHTHAL&VIS SCI/FPRC
Protocol Version 6/22/2023

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by University of Wisconsin, Madison

vitrectomy surgery

Additional relevant MeSH terms:

Retinal Detachment

Dissociative Disorders

Lamivudine

Study Results

No Results Posted as of Sep 28, 2023