This study is not yet accepting patients

Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A

a study on Fungal Keratitis Corneal Ulcer

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Gerami D Seitzman, MD

Description

Summary

The goal of this clinical trial is to learn if adjunctive topical Cyclosporine A eye drops combined with standard of care topical Natamycin treatment improves vision outcomes in patients with fungal keratitis.

Details

This is a randomized, masked, clinical trial of patients with documented fungal infections of the cornea. In this trial participants are treated with (standard of care) topical natamycin for a minimum of 48 hours and then randomized in a 1:1:1 ratio to receive either topical Cyclosporine A (CsA) 0.1%, or CsA 2%, or placebo for 4 weeks. Natamycin will be continued until the corneal ulcer has resolved. The primary outcome of this pilot trial is best corrected visual acuity (BCVA) at 3 months. The specific aims of this trial are to:

  • to determine if early use of topical cyclosporine A is a beneficial adjuvant to natamycin in the treatment of mild to moderate fungal keratitis.
  • to determine if adjunctive 2% cyclosporine A demonstrates greater efficacy than 0.1% cyclosporine A in the treatment of fungal keratitis.
  • to determine which ulcer characteristics, predict the most benefit from the addition of early topical cyclosporine.

In this study the investigators will partner with their cornea colleagues at the Aravind Eye Hospital. This is because the incidence of fungal corneal ulcers is among the highest in the world in this location.

Keywords

Fungal Keratitis, Corneal Ulcer, Cyclosporine A, Fungal Corneal Ulcer, Keratitis, Ulcer, Cyclosporine, Cyclosporins, Cyclosporine A (CsA) 0.1%, Cyclosporine A (CsA) 2%

Eligibility

You can join if…

Open to people ages 18 years and up

  • Inclusion is based on presenting acuity, not ulcer size.
  • Inclusion of 20/40 = 6/12 = 0.3 Log MAR and 20/400 = 3/60 = +1.3 Log MAR.
  • Smear or culture positive for fungal keratitis, any length.
  • Age 18 years.
  • Willing to participate in study.

You CAN'T join if...

  • Co-infection with bacterial or viral keratitis.
  • Corneal perforation.
  • Requiring therapeutic keratoplasty for fungal keratitis.
  • Unwilling or unable to follow up (e.g., living too far from hospital).
  • Presenting acuity better than 20/40 = 6/12 = 0.3 Log MAR or worse than 20/400 = 3/60 = +1.3 Log MAR.
  • Subjects taking cyclosporine at any concentration on presentation.
  • Acuity worse than 20/200 = 6/60 = +1.0 Log MAR in unaffected eye.
  • Pregnant women.
  • Penetrating Keratoplasty.
  • Presents with a 0-7 day history of topical steroid.

Locations

  • University of California, San Farncisco
    San Francisco California 94143 United States
  • Aravind Eye Institute
    Pondicherry Tamil Nadu 605 007 India

Lead Scientist at UCSF

  • Gerami D Seitzman, MD
    Gerami Seitzman, MD is an Associate Professor of Ophthalmology at the University of California, San Francisco. She is a cornea and external disease specialist at the F.I. Proctor Foundation. She also sees patients with cornea and external disease diagoses at the UCSF Department of Ophthalmology. A native of Michigan, she obtained her undergraduate and medical degrees at the University of Michigan.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT06658002
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 150 study participants
Last Updated