Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Samanthila Waduthantri, Singapore National Eye Centre Identifier:
First received: July 19, 2012
Last updated: November 16, 2015
Last verified: November 2015
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 Intervention
Cytomegalovirus Anterior Segment Infection
Anterior Uveitis
Drug: Ganciclovir

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • 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:
  • Correlation of intracameral concentration of virgan with the corneal thickness [ Time Frame: 6 weeks ]

Enrollment: 29
Study Start Date: July 2012
Study Completion Date: July 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ganciclovir
Treatment with topical ganciclovir ointment
Drug: Ganciclovir
Treatment with topical ganciclovir ointment


Ages Eligible for Study:   21 Years to 99 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01647529

Singapore National Eye Centre
Singapore, Singapore
Sponsors and Collaborators
Singapore National Eye Centre
Principal Investigator: Soon P Chee Singapore National Eye Centre
Study Chair: Gemmy Cheung Singapore National Eye Centre
  More Information

Responsible Party: Samanthila Waduthantri, Clinical Research Fellow, Clinical Associate, Singapore National Eye Centre Identifier: NCT01647529     History of Changes
Other Study ID Numbers: R733/17/2010
Study First Received: July 19, 2012
Last Updated: November 16, 2015

Keywords provided by Singapore National Eye Centre:

Additional relevant MeSH terms:
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 processed this record on April 21, 2017