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Anti-metabolites
5-Fluorouracil Injection for Chalazion (CTS Trial)
Phase 3
Recruiting
Led By Matthew M Zhang, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Single or multiple chalazia in a single eyelid
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
CTS Trial Summary
This trial found that 5-fluorouracil injected into a chalazion was as effective as a steroid injection or surgery.
Who is the study for?
This trial is for individuals with one or more chalazia (styes) on a single eyelid. Participants must have had the chalazion for at least one month and should not have received any previous injections or surgical treatments for it.Check my eligibility
What is being tested?
The study is testing the effectiveness of a local injection of 5-fluorouracil compared to an injection of triamcinolone (a steroid), a mixture of both, or surgery (incision and curettage) in treating chalazia.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, inflammation, possible skin discoloration, and eye irritation. The severity can vary from person to person.
CTS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have one or more chalazia on one eyelid.
CTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Meibomian Cyst
CTS Trial Design
4Treatment groups
Active Control
Group I: Injection of triamcinolone/5FU mixtureActive Control2 Interventions
0.1 ml of a 4:1 mixture of 4 parts 5-FU and 1 part triamcinolone is injected in the lesion.
Group II: Injection of Triamcinolone AcetonideActive Control2 Interventions
0.1 ml of triamcinolone is injected directly in the chalazion.
Group III: Incision and CurettageActive Control1 Intervention
A vertical incision over the area of chalazion will be done. Inflammatory material will be removed and the chalazion capsule will be excised.
Group IV: Injection of 5-fluorouracilActive Control2 Interventions
0.1 ml of 5-fluorouracil is injected directly in the lesion transconjunctivally.
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Who is running the clinical trial?
University of WashingtonLead Sponsor
1,739 Previous Clinical Trials
1,847,808 Total Patients Enrolled
Matthew M Zhang, MDPrincipal InvestigatorUniversity of Washington Eye Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My chalazion has been present for less than a month and hasn't been treated by injection or surgery.I have one or more chalazia on one eyelid.
Research Study Groups:
This trial has the following groups:- Group 1: Injection of triamcinolone/5FU mixture
- Group 2: Injection of Triamcinolone Acetonide
- Group 3: Incision and Curettage
- Group 4: Injection of 5-fluorouracil
Awards:
This trial has 4 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What conditions does the Injection of triamcinolone/5FU mixture typically help improve?
"The most common use for this triamcinolone/5FU mixture is to treat ulcerative colitis, however it can also be injected to help with conditions such as hand and brain non-immunocompromised."
Answered by AI
Are there other instances where this medication has been injected in patients?
"There are a total of 377 ongoing studies involving the injection of a triamcinolone/5FU mixture. 115 of those are clinical trials currently in progress, and the majority of those are located in Adelaide, South Australia. However, there are a total of 19148 locations running studies for this treatment."
Answered by AI
Has the FDA cleared triamcinolone/5FU mixture for use in injections?
"Injection of triamcinolone/5FU mixture is considered safe based on our team's estimation. This is a Phase 3 trial, meaning that there is both evidence of efficacy and safety."
Answered by AI
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