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Intraocular Amphotericin B and Voriconazole in fungal Keratitis treatment

Intracameral injection of Amphotericin B and Voriconazole in fungal keratitis treatment

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
REBEC
Registry ID
RBR-6rvjd2
Enrollment
Unknown
Registered
2020-03-10
Start date
2019-12-17
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fungal Keratitis

Interventions

Antifungal intracameral injection (voriconazole 50MCG/0,1ML and amphotericin B 5MCG/0,1ML), every 72 hours, until improvement or at most 5 injections. Ten patients will be recruited in each group (vor
Drug
C11.204.564

Sponsors

Departamento de Oftalmologia Universidade Federal de São Paulo
Lead Sponsor
Departamento de Oftalmologia da Universidade Federal de Uberlândia
Collaborator
Fundação Banco de Olhos de Goiás
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Patients with suspected fungal keratitis, with positive or ongoing culture, who do not show clinical improvement after 10 days of topical antifungal treatment or with anterior chamber involvement

Exclusion criteria

Exclusion criteria: Age under 12 years, affection limited to the anterior third of the corneal stroma; presence of corneal perforation, atalamy or scleral involvement; patients or guardians who do not agree to participate in the study

Design outcomes

Primary

MeasureTime frame
- Therapeutic corneal transplantation. After using the studied therapy (randomized medication), corneal transplantation will be indicated as rescue therapy for patients who present refractory symptoms, with no response to the medication administered. Clinical refractoriness will be considered as: absence of biomicroscopic improvement of the fungal keratitis after 5 therapeutic injections, perforation or imminence of corneal perforation and scleral involvement. Patients will be clinically assessed by slit lamp examination before randomization and at pre-specified times after the therapy studied. The transplant indication rate (%) will be calculated in each group for comparison

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactFernanda Bezerra Linhares

Departamento de Oftalmologia Universidade Federal de São Paulo

fernandamb1901@gmail.com+5511948552455

Outcome results

None listed

Source: REBEC (via WHO ICTRP)