NCT01647529

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

Intra-cameral Penetration of Ganciclovir Following Topical Administration of 0.15% Ganciclovir Gel (VIRGAN©) for CMV Anterior Uveitis / Endotheliitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Singapore National Eye Centre · Other Government
• Sex: All
• Age: 21 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytomegalovirus Anterior Segment Infection
• Anterior Uveitis
• Endotheliitis

Interventions

Type	Name	Description
DRUG	Ganciclovir	Treatment with topical ganciclovir ointment

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-07-01
• Completion: 2014-07-01
• First posted: 2012-07-23
• Last updated: 2015-11-18

Locations

1 site across 1 country: Singapore