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Completed

NCT Number: NCT01647529

Topical Administration of 0.15% Ganciclovir Gel 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.

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Key information

Conditions

Cytomegalovirus Anterior Segment Infection Amino Acid Metabolism, Inborn Errors Anterior Uveitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endotheliitis Eye Diseases Genetic Diseases, Inborn Metabolic Diseases Metabolism, Inborn Errors Mitochondrial Diseases Multiple Acyl Coenzyme A Dehydrogenase Deficiency Nutritional and Metabolic Diseases Panuveitis Uveal Diseases Uveitis Uveitis, Anterior

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Singapore National Eye Centre

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ganciclovir

Drug

Treatment with topical ganciclovir ointment

Primary outcomes

  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 outcomes

  1. Correlation of intracameral concentration of virgan with the corneal thickness

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Singapore National Eye Centre

Other Gov

Registry information

Official study title

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

Acronym: Virgan

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jul 23, 2012
Registry last updated
Nov 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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