Fungal Ulcer Treatment Augmented With Natamycin and Cyclosporine A (FANCY)

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 3

Conditions: Fungal Keratitis; Corneal Ulcer

Treatments: Other: Placebo Comparator: Placebo; Drug: Cyclosporine A

Study type: Interventional

Funder types: Other

Identifiers

NCT06658002

24-41971

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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150 participants in 3 patient groups, including a placebo group

Cyclosporine A (CsA) 0.1%

Experimental group

Description:

After one week of hourly natamycin eye drops the participants in this arm will use this drop four times a day for one month then twice a day for one month.

Treatment:

Drug: Cyclosporine A

Cyclosporine A (CsA) 2%

Experimental group

Description:

After one week of hourly natamycin eye drops the participants in this arm will use this drop four times a day for one month then twice a day for one month.

Treatment:

Drug: Cyclosporine A

Placebo

Placebo Comparator group

Description:

After one week of hourly natamycin eye drops the participants in this arm will use this drop four times a day for one month then twice a day for one month.

Treatment:

Other: Placebo Comparator: Placebo