Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers

• Status: Completed
• Trial end date: 2018-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborator: Aravind Eye Hospitals, India
• Treatments: Natamycin; Voriconazole

Criteria

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