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Eligibility
for people ages 18 years to 70 years
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator

Description

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.

Details

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.

Keywords

Corneal Ulcer Fungal Keratitis cornea ulcer fungal keratitis Voriconazole Natamycin

Eligibility

You can join if…

Open to people ages 18 years to 70 years

  • 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

You CAN'T join if...

  • 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

Locations

  • Aravind Eye Hospitals
    Pondicherry, Tamil Nadu, India

Details

Status
accepting new patients by invitation only
Start Date
Sponsor
University of California, San Francisco
ID
NCT02731638
Phase
Phase 3
Lead Scientist
Jennifer Rose-Nussbaumer
Study Type
Interventional
Last Updated
December 2016