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Mycotic Ulcer Treatment Trial II

2014-07-23 21:12:26 | BioPortfolio

Summary

The purpose of this study is to determine if the addition of oral voriconazole to topical treatment regimens results in lower rates of perforation in severe fungal corneal ulcers.

Description

Fungal corneal ulcers tend to have very poor outcomes with commonly used treatments. There has only been a single randomized trial of anti-fungal therapy for mycotic keratitis, and no new ocular anti-fungal medications have been approved by the FDA since the 1960s. The triazole voriconazole has recently become the treatment of choice for systemic fungal infections such as pulmonary aspergillosis. The use of topical ophthalmic preparations of voriconazole has been described in numerous case reports, however there has been no systematic attempt to determine whether it is more or less clinically effective than natamycin. Additionally, there have been many case reports of the use of oral voriconazole in the treatment of fungal corneal ulcers, however there has been no systematic attempt to determine if it improves outcomes in severe ulcers.

This study is a randomized, double-masked, placebo-controlled trial to determine if the use of oral voriconazole in severe ulcers reduces the rate of perforations. 240 fungal corneal ulcers with baseline visual acuity worse than 6/120 presenting to the Aravind Eye Hospitals and the UCSF Proctor Foundation will be randomized to receive topical voriconazole and oral voriconazole, or topical voriconazole and oral placebo. The primary outcome is the rate of perforation over the three month follow-up period.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Corneal Ulcer

Intervention

Voriconazole, Placebo

Location

Proctor Foundation, UCSF
San Francisco
California
United States
94143

Status

Recruiting

Source

University of California, San Francisco

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:12:26-0400

Clinical Trials [545 Associated Clinical Trials listed on BioPortfolio]

Mycotic Ulcer Treatment Trial I

The purpose of this study is to determine if natamycin or voriconazole results in better visual outcomes in fungal corneal ulcers, especially visual acuity.

Therapeutic Exploratory Study of Comparing Natamycin and Voriconazole to Treat Fungal Corneal Ulcer

We are planning to evaluate whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. The study being proposed...

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The primary purpose of this study is to determine if patients randomized to corneal collagen cross-linking plus medical therapy will have a lower prevalence of positive bacterial or fungal...

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The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.

PubMed Articles [1589 Associated PubMed Articles listed on BioPortfolio]

Novel Image-Based Analysis for Reduction of Clinician-Dependent Variability in Measurement of the Corneal Ulcer Size.

To assess variability in corneal ulcer measurements between ophthalmologists and reduce clinician-dependent variability using semiautomated segmentation of the ulcer from photographs.

Microemulgel of Voriconazole: an Unfathomable Protection to Counter Fungal Contagiousness.

Fluconazole and ketoconazole both have poor minimum inhibitory concentration than voriconazole. Voriconazole had serious side effects in oral and intravenous doses. It has poor water solubility. The o...

Corneal Collagen Cross-Linking for the Management of Mycotic Keratitis.

To evaluate the efficiency of corneal collagen cross-linking (CXL) in addition to topical voriconazole in cases with mycotic keratitis.

Surgery treatment of purulent corneal ulcers associated with neuroparalytic keratitis.

The study objective was to develop a method for surgical treatment of advanced purulent corneal ulcer in the setting of neuroparalytic keratitis developed after acoustic neuroma removal and strokes.

Conjunctival Hyperemia or Vasodilation and Central Corneal Ulcer in a Neonate.

Medical and Biotech [MESH] Definitions

New blood vessels originating from the corneal veins and extending from the limbus into the adjacent CORNEAL STROMA. Neovascularization in the superficial and/or deep corneal stroma is a sequel to numerous inflammatory diseases of the ocular anterior segment, such as TRACHOMA, viral interstitial KERATITIS, microbial KERATOCONJUNCTIVITIS, and the immune response elicited by CORNEAL TRANSPLANTATION.

Loss of epithelial tissue from the surface of the cornea due to progressive erosion and necrosis of the tissue; usually caused by bacterial, fungal, or viral infection.

The measurement of curvature and shape of the anterior surface of the cornea using techniques such as keratometry, keratoscopy, photokeratoscopy, profile photography, computer-assisted image processing and videokeratography. This measurement is often applied in the fitting of contact lenses and in diagnosing corneal diseases or corneal changes including keratoconus, which occur after keratotomy and keratoplasty.

A PEPTIC ULCER located in the DUODENUM.

Fibroblasts which occur in the CORNEAL STROMA.

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