Retinal DetachmentEarly Phase 1NCT06056596
Lamivudine and Plasma Markers of Inflammation in Retinal Detachment
A Early Phase 1 study testing Lamivudine 300 MG in people with Retinal Detachment and Rhegmatogenous Retinal Detachment, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Retinal Detachment, Rhegmatogenous Retinal Detachment
- What is being tested?
- Lamivudine 300 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2024to 6 Sep 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 or ≤ 75 years
- Patients with rhegmatogenous retinal detachment that require vitrectomy surgery
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-ocular Penetration of Oral Lamivudine and Measurement of Systemic Inflammatory Markers in Patients Undergoing Rhegmatogenous Retinal Detachment Surgery
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).
Read the 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.
- Being tested
- Lamivudine 300 MG, Placebo
- Keywords
- vitrectomy surgery
- Medical subject headings
- Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lamivudine 300 MGDrug
Drug to be taken once daily for three days (two days prior to surgery and on the morning of surgery)
PlaceboDrug
Dose to be taken once daily for three days (two days prior to surgery and on the morning of surgery)
| Study group | Role | What they receive |
|---|---|---|
| Lamivudine | Experimental | Lamivudine 300mg PO once daily for three days Receives: Drug: Lamivudine 300 MG |
| Placebo | Placebo comparator | Placebo once daily for three days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of lamivudine after oral administration
Mean concentration of lamivudine in plasma
Measured: Pre-operative
Intra-ocular concentration of lamivudine after oral administration
Mean concentration of lamivudine in vitreous and aqueous humor
Measured: Intra-operatively
Secondary outcomes (5)
Change in erythrocyte sedimentation rate (millimeter per hour)
Mean concentration of inflammatory markers will in part be measured by erythrocyte sedimentation rate.
Measured: Pre-operative to one week post-operative
Change in C-reactive protein (milligrams per liter)
Mean concentration of inflammatory markers will in part be measured by C-reactive protein.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Pre-operative to one week post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start30 Jan 2024
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Why it stopped: Treatment approach changed, and insufficient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DetachmentStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Altaweel, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056596
- Sponsor's protocol ID
- 2022-1223
- Other IDs
- SMPH/OPHTHAL&VIS SCI/FPRC, Protocol Version 1/29/2024
- Status last verified
- Sep 2024
- First submitted
- 1 Aug 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-ocular Penetration of Oral Lamivudine and Measurement of Systemic Inflammatory Markers in Patients Undergoing Rhegmatogenous Retinal Detachment Surgery
- ClinicalTrials.gov ID
- NCT06056596
- Acronym / sponsor ID
- 2022-1223
- Keywords
- vitrectomy surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Treatment approach changed, and insufficient population
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lamivudine | Experimental | Drug: Lamivudine 300 MGLamivudine 300mg PO once daily for three days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily for three days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 or ≤ 75 years
- Patients with rhegmatogenous retinal detachment that require vitrectomy surgery
Key exclusion criteria (14 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lamivudine 300 MGDrug to be taken once daily for three days (two days prior to surgery and on the morning of surgery) | Drug | Lamivudine |
| PlaceboDose to be taken once daily for three days (two days prior to surgery and on the morning of surgery) | Drug | Placebo |
Primary outcome
Plasma concentration of lamivudine after oral administration
Time frame: Pre-operative
Mean concentration of lamivudine in plasma
Intra-ocular concentration of lamivudine after oral administration
Time frame: Intra-operatively
Mean concentration of lamivudine in vitreous and aqueous humor
5 secondary outcomes
Change in erythrocyte sedimentation rate (millimeter per hour)
Time frame: Pre-operative to one week post-operative
Change in C-reactive protein (milligrams per liter)
Time frame: Pre-operative to one week post-operative
Change in concentration of inflammatory markers (picogram per milliliter)
Time frame: Pre-operative to one week post-operative
Change in concentration of inflammatory markers (micrograms per milliliter)
Time frame: Pre-operative to one week post-operative
Change in concentration of soluble IL-2 receptor alpha (Units per milliliter)
Time frame: Pre-operative to one week post-operative
Results and safety
The study was stopped early (reason given: Treatment approach changed, and insufficient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
Related trials for Retinal Detachment
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RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
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Recruiting
Retinal Detachment Prevention (Laser Prophylaxis) in Stickler Syndrome (SS)
Stickler Syndrome Type 1, Stickler Syndrome Type 2
RecruitingObservational study
Intraoperative OCT Guidance of Intraocular Surgery II
Macular Holes, Epiretinal Membrane
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Altaweel, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Lamivudine 300 MG in people with Retinal Detachment and Rhegmatogenous Retinal Detachment, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Treatment approach changed, and insufficient population). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma concentration of lamivudine after oral administration (time frame: Pre-operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.