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| ID | Type | Description | Link |
|---|---|---|---|
| SMPH/OPHTHAL&VIS SCI/FPRC | Other Identifier | UW Madison | |
| Protocol Version 1/29/2024 | Other Identifier | UW Madison |
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Treatment approach changed, and insufficient population
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamivudine | Experimental | Lamivudine 300mg PO once daily for three days |
|
| Placebo | Placebo Comparator | Placebo once daily for three days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine 300 MG | Drug | Drug to be taken once daily for three days (two days prior to surgery and on the morning of surgery) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in erythrocyte sedimentation rate (millimeter per hour) | Mean concentration of inflammatory markers will in part be measured by erythrocyte sedimentation rate. | Pre-operative to one week post-operative |
| Change in C-reactive protein (milligrams per liter) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Altaweel, MD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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| Placebo | Drug | Dose to be taken once daily for three days (two days prior to surgery and on the morning of surgery) |
|
Mean concentration of inflammatory markers will in part be measured by C-reactive protein. |
| Pre-operative to one week post-operative |
| 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. | Pre-operative to one week post-operative |
| 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) | Pre-operative to one week post-operative |
| 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. | Pre-operative to one week post-operative |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |