Background/aims The aim of this study was to evaluate the therapeutic efficacy and drug transfer of topical application of 0.15% ganciclovir (GCV) gel on cytomegalovirus (CMV) corneal endotheliitis.
Methods This study is a multicentre, prospective, interventional case series. Seven eyes of seven immunocompetent patients diagnosed with CMV corneal endotheliitis, based on clinical manifestations and qualitative PCR, were enrolled in this study. The patients were treated with topical applications of 0.15% GCV gel six times daily for 12 weeks without concomitant systemic GCV. Clinical evaluations and quantitative PCR of CMV were performed, and GCV concentrations in aqueous humour were measured by liquid chromatography/tandem mass spectrometry.
Results Clinical improvement of coin-shaped lesions, other types of keratic precipitates, corneal oedema, and anterior chamber inflammation was confirmed at the 4-week visit in all seven eyes. The GCV treatment significantly decreased the CMV copy numbers (p<0.0001). After 12 weeks of treatment, six eyes recovered clear corneas with good vision, and endothelial function was well maintained. Detectable levels of GCV were confirmed in the aqueous humour of all the eyes. The mean GCV concentration in the anterior chamber was 162.0±202.4 ng/mL. The re-emergence of CMV without symptoms was observed in one eye with lower drug transfer. No side effects were observed.
Conclusions Clinical improvement and reduced CMV copy numbers in the aqueous humour were confirmed in the CMV corneal endotheliitis cases. Although the case numbers are limited and long-term follow-up is necessary, the topical application of 0.15% GCV gel appears to be a useful treatment option for CMV endotheliitis.
Trial registration number UMIN000012435.
- Treatment Medical
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Contributors NK, DM and TI: conception and design of the work, the acquisition, analysis and interpretation of data. Drafting the work. FO, MK-I, TI, CS, HN, TH, MU and TN: the acquisition, analysis of data. Drafting the work. YI, YO and SK: the analysis and interpretation of data. Revising the work critically for important intellectual content. Final approval of the version published was obtained by all authors. Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved by all authors.
Funding This study was partially supported by M's Science Corporation, Kobe, Japan. M's science provided 0.15% GCV gel and research consumables for real-time PCR for this study.
Competing interests None declared.
Ethics approval Institutional Review Boards of Kyoto Prefectural University of Medicine, Tottori University, and Ehime University.
Provenance and peer review Not commissioned; externally peer reviewed.