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

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

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.

Study Overview

• Status: Completed
• Conditions: Anterior Uveitis; Cytomegalovirus Anterior Segment Infection; Endotheliitis
• Intervention / Treatment: Drug: Ganciclovir

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Singapore National Eye Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 21 and above
• Patients who are diagnosed with anterior uveitis or endotheliitis with a positive aqueous real time PCR (RT-PCR) and/or positive tetraplex PCR for Cytomegalovirus (CMV)
• Patients with relapses and recurrent anterior segment disease that is PCR positive for CMV in aqueous
• Have not been on VIRGAN or any other form of ganciclovir therapy for the past 1 month
• Consent to undergo anterior chamber tap and give aqueous and tear samples for the study
• Able to undergo relevant tests (corneal pachymetry and laser flare cell photometry)
• Able to come for subsequent follow-up visits

Exclusion Criteria:

• CMV anterior uveitis with associated retinitis
• Other causes of hypertensive anterior uveitis / endotheliitis such as HSV, VZV infection
• Patients who have been on any form of (topical, local or systemic) ganciclovir therapy for the past1 month.
• Patients who are allergic to ganciclovir
• Patients who will require systemic or intra-vitreal ganciclovir therapy
• Immunocompromised patients
• Positive for HIV, Hep B and Hep C
• Not keen on participating in the study
• Patients who are incapable, either by law or mental state, of giving consents in their own right.
• Patients who are either unable or unwilling to keep scheduled appointments and adhere to the other aspects of the protocol
• Patients who are pregnant or breastfeeding
• Any other specified reason as determined by the clinical investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ganciclovir; Treatment with topical ganciclovir ointment	Drug: Ganciclovir; Treatment with topical ganciclovir ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median concentration of ganciclovir in anterior chamber and ocular surface	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.	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation of intracameral concentration of virgan with the corneal thickness	6 weeks

Collaborators and Investigators

• Sponsor: Singapore National Eye Centre
• Investigators: Principal Investigator: Soon P Chee, Singapore National Eye Centre; Study Chair: Gemmy Cheung, Singapore National Eye Centre

Publications and helpful links

General Publications

• Waduthantri S, Zhou L, Chee SP. Intra-cameral level of ganciclovir gel, 0.15% following topical application for cytomegalovirus anterior segment infection: A pilot study. PLoS One. 2018 Jan 29;13(1):e0191850. doi: 10.1371/journal.pone.0191850. eCollection 2018.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimate): July 23, 2012

Study Record Updates

• Last Update Posted (Estimate): November 18, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Cytomegalovirus; uveitis; ganciclovir; endotheliitis
• Additional Relevant MeSH Terms: Eye Diseases; Panuveitis; Uveal Diseases; Iris Diseases; Uveitis; Uveitis, Anterior; Iridocyclitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Ganciclovir; Ganciclovir triphosphate
• Other Study ID Numbers: R733/17/2010