Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/8/2018 |
| Start Date: | September 2016 |
| End Date: | July 2018 |
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.
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.
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.
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.
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
We found this trial at
2
sites
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