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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Singapore National Eye Centre

Current Primary Outcome: Median concentration of ganciclovir in anterior chamber and ocular surface [ Time Frame: 6 weeks ]

Following 6 weeks of continuous application of Virgan gel 0.15% 1cc 5 times a day, the patient will be reviewed at the clinic within 3 hours following the last application of the gel.


Original Primary Outcome: Same as current

Current Secondary Outcome: Correlation of intracameral concentration of virgan with the corneal thickness [ Time Frame: 6 weeks ]

Original Secondary Outcome: Same as current

Information By: Singapore National Eye Centre

Dates:
Date Received: July 19, 2012
Date Started: July 2012
Date Completion:
Last Updated: November 16, 2015
Last Verified: November 2015