NCT02943057

Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis

Intra-cameral Penetration and Efficacy of Ganciclovir Following Topical Administration of 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Singapore National Eye Centre · Other Government
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

25 patients who are diagnosed with Cytomegalovirus (CMV) anterior segment infection, either uveitis or endotheliitis, will be started on 2% guttae ganciclovir, 1 drop 5 times a day for 6 weeks. Following 6 weeks of continuous application of 2% guttae ganciclovir, patient will be reviewed at the clinic within 3 hours following the last application of topical ganciclovir and clinical features will be documented for activity assessment. An aqueous sample 0.2ml is drawn. 0.1ml will be sent for RT-PCR for CMV viral load and another 0.1ml will be sent for ganciclovir drug level by HPLC method.

Detailed description

This is non-randomised single armed prospective, cross-sectional, interventional clinical study. 25 patients who are diagnosed with Cytomegalovirus (CMV) anterior segment infection, either uveitis or endotheliitis, at the investigators clinic in Singapore National Eye Centre, 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. This will also include the patients who have never been treated with antiviral therapy and those with recurrent disease and have not had any form of ganciclovir treatment for past 1 month. The clinical features of the active disease will be recorded in the data collection sheet and will include, documentation of the state of the cornea, KPs, AC cells, flare, flare meter reading (where possible), central corneal thickness, Intra ocular pressure (IOP) and C:D ratio. All patients will be started on 2% guttae ganciclovir, 1 drop 5 times a day. 2% Guttae ganciclovir will be prepared from vials of ganciclovir powder for ganciclovir intravenous infusion using aseptic method. Following 6 weeks of continuous application of 2% guttae ganciclovir, patient will be reviewed at the clinic within 3 hours following the last application of topical ganciclovir. 1. Clinical features mentioned above will be documented for activity assessment 2. Following irrigation of the conjunctival sac with 100ml of N/S to wash out any residual drug, aseptic technique is practised before an aqueous sample 0.2ml is drawn. 0.1ml will be sent for RT-PCR for CMV viral load and another 0.1ml will be sent for ganciclovir drug level by HPLC method.

Conditions

• Cytomegalovirus Infections

Interventions

Type	Name	Description
DRUG	2% guttae ganciclovir	2% guttae ganciclovir 5 times a day for 6 weeks

Timeline

• Start date: 2016-10-01
• Primary completion: 2024-01-01
• Completion: 2024-11-30
• First posted: 2016-10-24
• Last updated: 2025-05-18

Locations

1 site across 1 country: Singapore