At a glance
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Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers
In Brief
A Phase 3 clinical trial evaluating Intrastromal voriconazole and Natamycin for Corneal Ulcer and Fungal Keratitis. Completed, enrolled 70 participants across 2 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Subjects will receive three intrastromal voriconazole injections over 10 days. Intrastromal voriconazole injection is a routine procedure performed by Aravind Eye Hospital for fungal keratitis.
Subjects will receive topical 5% natamycin drops hourly for 3 days.