drugset / Trial / NCT01647529

Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis

NCT01647529

Completed 29 enrolled Singapore National Eye Centre
NaSingle-groupOpen-labelTreatment

Summary

Objective of this study is to investigate the intracameral level of ganciclovir following topical application of 0.15% ganciclovir gel (VIRGAN©) for Cytomegalovirus (CMV) anterior uveitis and endothelitis. Thirty patients who are diagnosed with CMV anterior segment infection, either uveitis or endothelitis, who have a positive aqueous real time PCR (RT-PCR) and/or positive tetraplex PCR for CMV and have not had any form of ganciclovir treatment in the past 1 month, will be recruited in the study after taking an informed consent. with active CMV anterior segment infection confirmed by a positive aqueous real time PCR (RT-PCR) and have not had any form of ganciclovir treatment in the past 1 month were recruited in the study. Patients were given 0.15% ganciclovir gel 1cc 5 times a day for 6 weeks. Following 6 weeks of treatment, tears and aqueous samples will be collected. Aqueous will be sent for RT-PCR for CMV status. Ganciclovir drug level in both tears and aqueous will be measured by HPLC method. Clinically, degree of the intraocular inflammation, Intraocular pressure (IOP) and central corneal thickness (CCT) will be recorded at baseline and post-treatment.

Timeline

Start
2012-07
Primary completion
2013-07
Completion
2014-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Ganciclovir Small molecule 0.15 % Topical
Subject Ganciclovir Small molecule 1 ml Topical