120 Participants Needed

5-Fluorouracil Injection for Chalazion

(CTS Trial)

IL
Simona Vuletic, MD profile photo
Overseen BySimona Vuletic, MD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Washington
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares different treatments for eyelid lumps called chalazia. The treatments include medicine injections or minor surgery. The goal is to see which method best reduces or removes these lumps. Injections have been used effectively in treating chalazia, showing high success rates in previous studies.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is 5-Fluorouracil generally safe for humans?

5-Fluorouracil (5-FU) is used in various treatments, including skin cancer and eye surgeries, and is generally considered safe when used as directed. Some studies show that it can cause mild skin irritation, but formulations like bioadhesive gels can reduce this risk. However, it can be toxic if ingested, especially in animals.12345

How does the drug 5-fluorouracil injection differ from other treatments for chalazion?

5-fluorouracil injection is unique because it is typically used to inhibit cell growth and scar formation, which is not a common approach for treating chalazion. This drug is often used in eye surgeries to prevent excessive tissue growth, suggesting a novel mechanism for addressing chalazion by potentially reducing inflammation and promoting healing.26789

What data supports the effectiveness of the drug 5-fluorouracil injection for treating chalazion?

Research shows that 5-fluorouracil (5-FU) has been used successfully in eye-related treatments, such as improving outcomes in glaucoma surgeries and treating severe dry eye disease. This suggests it may have potential benefits for other eye conditions like chalazion.7891011

Who Is on the Research Team?

MM

Matthew M Zhang, MD

Principal Investigator

University of Washington Eye Institute

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have one or more chalazia on one eyelid.

Exclusion Criteria

My chalazion has been present for less than a month and hasn't been treated by injection or surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of the four standard-of-care treatments for chalazia: incision and curettage, local injection of triamcinolone, local injection of 5-FU, or local injection of combination triamcinolone/5-FU

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • 5-fluorouracil Injection
  • Triamcinolone Acetonide
Trial Overview 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.
How Is the Trial Designed?
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.

5-fluorouracil Injection is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as Fluorouracil for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer
  • Oesophageal cancer
  • Cervical cancer
  • Skin cancers
πŸ‡ΊπŸ‡Έ
Approved in United States as Fluorouracil for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer
  • Anal cancer
  • Cervical cancer
  • Head and neck cancers
  • Skin cancers
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Approved in Canada as Fluorouracil for:
  • Colorectal cancer
  • Breast cancer
  • Stomach cancer
  • Pancreatic cancer
  • Oesophageal cancer
  • Cervical cancer
  • Skin cancers

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials
1,858
Recruited
2,023,000+

Published Research Related to This Trial

In a study of 63 glaucomatous eyes undergoing filtering surgery, the adjusted use of 5-fluorouracil (5-FU) injections led to successful surgical outcomes in a significant number of cases, with 87% success in aphakic eyes and 92% in eyes with previous failed filters.
While the approach of tailoring 5-FU dosage based on clinical response showed promise in reducing complications, such as conjunctival wound leaks and corneal toxicity, further validation through controlled randomized clinical trials is necessary to confirm its safety and efficacy.
Adjusting the dose of 5-fluorouracil after filtration surgery to minimize side effects.Weinreb, RN.[2022]
Subconjunctival injections of 5-fluorouracil (5-FU) in patients with failed filtering blebs after glaucoma surgery resulted in significant cytological changes, including squamous metaplasia and nuclear atypia in the conjunctival epithelium, observed in 60% of treated eyes.
The study involved 15 patients receiving 5-FU, and while changes were noted, the small sample size limited the ability to draw significant comparisons with other groups, including those treated with antiglaucomatous eyedrops and healthy controls.
Short-term effects of subconjunctival injections of 5-fluorouracil on conjunctival epithelium.Simsek, T., Firat, P., Citirik, M., et al.[2013]
In a study of 29 eyes from 27 patients with high-risk glaucoma, 89.6% achieved controlled intraocular pressure after receiving subconjunctival injections of 5-Fluorouracil following filtering surgery, indicating its efficacy in managing difficult cases.
Despite its effectiveness, the treatment is associated with significant side effects, including conjunctival fistulas in 24% of cases and corneal epithelial breakdown in 69%, suggesting that while beneficial for high-risk patients, 5-Fluorouracil should not be used for standard glaucoma surgeries due to potential toxicity and complications.
[5-fluorouracil injection treatment after fistulating glaucoma operations].Reinhard, T., KlΓΌppel, M., Sundmacher, R.[2013]

Citations

Adjusting the dose of 5-fluorouracil after filtration surgery to minimize side effects. [2022]
Short-term effects of subconjunctival injections of 5-fluorouracil on conjunctival epithelium. [2013]
[5-fluorouracil injection treatment after fistulating glaucoma operations]. [2013]
Effects of varying 5-fluorouracil exposure duration on tenon's capsule fibroblasts. [2019]
5-Fluorouracil as a targeted lacrimal gland therapy for chronic Stevens-Johnson syndrome: A pilot study. [2023]
5-Fluorouracil in initial trabeculectomy. A prospective, randomized, multicenter study. [2019]
Sustained release of 5-fluorouracil from ethylene acetate copolymer. [2019]
8.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Development, characterization and in vivo localization study of topical 5-fluorouracil gels: a comparative study with conventional formulation. [2022]
5-Fluorouracil Management of Oculofacial Scars: A Systematic Literature Review. [2021]
Transient chemotherapy-induced alopecia after successful reversal of 5-fluorouracil myelosuppression and neurotoxicosis in a 9-month-old dog. [2022]
Treatment of Laser Resistant Granuloma Faciale with Intralesional Triamcinolone acetonide and 5-Fluorouracil Combination Therapy. [2020]
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