Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers (MALIN)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 3

Conditions: Fungal Keratitis; Corneal Ulcer

Treatments: Drug: Natamycin; Drug: Intrastromal voriconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT02731638

15-17989

Details and patient eligibility

About

Mycotic Antimicrobial Localized Injection (MALIN) is a randomized, masked, two-arm clinical trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers. There is currently little evidence to guide the treatment of fungal keratitis beyond topical anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used as well. This study will provide evidence to guide the treatment of fungal keratitis in the future. The purpose of this study is to determine differences in microbiological cure for 3-day repeat cultures between different antifungal treatments. For this study, there will be 1:1 randomization to one of these two treatment groups: 1) topical natamycin plus intrastromal voriconazole injection or 2) topical natamycin alone.

Full description

The proposed study is a randomized controlled trial to determine whether intrastromal voriconazole improves outcomes in fungal keratitis. Patients presenting to the Aravind Eye Hospitals in Pondicherry, India for treatment of fungal keratitis will be recruited for the proposed study. Approximately 70 patients will be enrolled in the study. Subjects presenting with fungal keratitis will be randomized to receive topical natamycin plus intrastromal voriconazole or to receive topical natamycin alone. Subjects may also receive oral antifungals after day 3 at the discretion of the treating clinician. All study subjects will be followed for 3 months to evaluate response to treatment.

Investigators from the University of California, San Francisco (UCSF) will assist Aravind Eye Hospital with the study design, implementation, and analysis of the research, and will help fund the study. The investigators will visit Aravind to help with the study implementation. UCSF will play an important role in this study by assisting with the study design, implementation, analysis, and funding.

Enrollment: 70 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe corneal ulcer that is smear positive for filamentous fungus
• Pinhole visual acuity worse than 20/70 in affected eye
• Basic understanding of the study as determined by the physician
• Commitment to return for follow up visits

Exclusion criteria

• Gram stain positive for bacteria or evidence of other concomitant infection (i.e. herpes, acanthamoeba)
• Impending or frank perforation at recruitment
• Involvement of sclera at presentation
• Non-infectious or autoimmune keratitis
• History of corneal transplantation or recent intraocular surgery
• No light perception in the affected eye
• Pinhole visual acuity worse than 20/200 in the unaffected eye
• Pregnant women
• Participants who are decisionally and/or cognitively impaired

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Intrastromal voriconazole plus natamycin

Experimental group

Description:

Intrastromal voriconazole plus standard of care topical treatment for fungal keratitis

Treatment:

Drug: Intrastromal voriconazole

Drug: Natamycin

Natamycin alone

Active Comparator group

Description:

Standard of care topical treatment for fungal keratitis

Treatment:

Drug: Natamycin