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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01647529
Recruitment Status : Completed
First Posted : July 23, 2012
Last Update Posted : November 18, 2015
Information provided by (Responsible Party):
Samanthila Waduthantri, Singapore National Eye Centre

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : July 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2014

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

Primary Outcome Measures :
  1. 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01647529

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Singapore National Eye Centre
Singapore, Singapore
Sponsors and Collaborators
Singapore National Eye Centre
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Principal Investigator: Soon P Chee Singapore National Eye Centre
Study Chair: Gemmy Cheung Singapore National Eye Centre
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Samanthila Waduthantri, Clinical Research Fellow, Clinical Associate, Singapore National Eye Centre Identifier: NCT01647529    
Other Study ID Numbers: R733/17/2010
First Posted: July 23, 2012    Key Record Dates
Last Update Posted: November 18, 2015
Last Verified: November 2015
Keywords provided by Samanthila Waduthantri, Singapore National Eye Centre:
Additional relevant MeSH terms:
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Uveitis, Anterior
Uveal Diseases
Eye Diseases
Iris Diseases
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action