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

Sponsor

Singapore National Eye Centre (Other)

Overall Status

Completed

CT.gov ID

NCT01647529

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Anterior Segment Infection Anterior Uveitis Endotheliitis	Drug: Ganciclovir	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Ganciclovir

Treatment with topical ganciclovir ointment

Drug: Ganciclovir

Treatment with topical ganciclovir ointment

Outcome Measures

Primary Outcome Measures

Median concentration of ganciclovir in anterior chamber and ocular surface [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.

Secondary Outcome Measures

Correlation of intracameral concentration of virgan with the corneal thickness [6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.