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Antiviral

Lamivudine for Retinal Detachment

Phase < 1
Recruiting
Led By Michael Altaweel, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 or ≤ 65 years
Patients with rhegmatogenous retinal detachment that require vitrectomy surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operative to one week post-operative
Awards & highlights

Study Summary

This trial will test if taking an oral medication can reduce inflammation in the eye after surgery.

Who is the study for?
This trial is for adults aged 18 to 65 with a specific eye condition called rhegmatogenous retinal detachment needing surgery. It's not for those with diabetes on insulin, anemia, certain infections like Hepatitis B/HIV, pregnancy, breastfeeding, liver or severe kidney issues, uncontrolled high blood pressure, current eye bleeding or previous eye surgeries in the affected eye.Check my eligibility
What is being tested?
The study tests if lamivudine (an oral drug) can reduce inflammation markers in the blood of patients undergoing retinal detachment surgery. Participants will receive either lamivudine or a placebo. Researchers will check inflammation levels and drug presence in the blood and inside the eye.See study design
What are the potential side effects?
While side effects are not explicitly listed here, common ones associated with lamivudine include headache, fatigue, nausea and occasionally more serious reactions such as liver problems or resistance to medication.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I need surgery for a detached retina.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operative to one week post-operative
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative to one week post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intra-ocular concentration of lamivudine after oral administration
Plasma concentration of lamivudine after oral administration
Secondary outcome measures
Change in C-reactive protein (milligrams per liter)
Change in concentration of inflammatory markers (micrograms per milliliter)
Change in concentration of inflammatory markers (picogram per milliliter)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LamivudineExperimental Treatment1 Intervention
Lamivudine 300mg PO once daily for three days
Group II: PlaceboPlacebo Group1 Intervention
Placebo once daily for three days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lamivudine 300 MG
2020
Completed Phase 4
~250

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,511 Total Patients Enrolled
1 Trials studying Retinal Detachment
101 Patients Enrolled for Retinal Detachment
Michael Altaweel, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
2 Previous Clinical Trials
356 Total Patients Enrolled
1 Trials studying Retinal Detachment
101 Patients Enrolled for Retinal Detachment

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial encompass participants aged 75 or above?

"The eligibility requirements for this clinical trial mandate that participants are aged 18 or older, with a maximum age limit of 65."

Answered by AI

Am I eligible to be enrolled in this experiment?

"This clinical trial is seeking 20 individuals between the ages of consent and 65 who have been diagnosed with retinal detachment. To be considered for this study, participants must also meet additional criteria: They require vitrectomy surgery to treat their rhegmatogenous condition."

Answered by AI

Does this medical study offer patient participation opportunities at present?

"As indicated on clinicaltrials.gov, this medical trial is not open for recruitment at present. It was first posted in October 1st 2023 but hasn't been updated since September 20th of the same year. Nonetheless, there are still 37 other trials looking to enroll patients currently."

Answered by AI

What is the ultimate purpose of this clinical trial?

"The primary goal of this medical investigation is to assess the intra-ocular concentration of lamivudine after oral administration over a pre-operative period. Secondary outcomes such as changes in C-reactive protein, tumor necrosis factor alpha, interleukin (IL)-18, IL-1 beta, IL-6, IL-10 MCP 1MIP 1 alphaGMCSF and Interferon (IFN) alpha , IFN Beta and IFN Gamma will be measured in milligrams per liter or picograms/micrograms per milliliter respectively."

Answered by AI
~10 spots leftby Aug 2024