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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Singapore National Eye Centre
Sponsor:
Information provided by (Responsible Party):
Samanthila Waduthantri, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01647529
First received: July 19, 2012
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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
Endotheliitis
Drug: Ganciclovir

Study Type: Interventional
Study Design: Endpoint Classification: Bio-availability Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated 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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01647529

Contacts
Contact: Samanthila Waduthantri samanthila.waduthantri@snec.com.sg

Locations
Singapore
Singapore National Eye Centre Recruiting
Singapore, Singapore
Contact: Wei H Teng         
Principal Investigator: Samanthila Waduthantri         
Principal Investigator: Soon Phaik Chee         
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
Principal Investigator: Soon P Chee Singapore National Eye Centre
Study Chair: Gemmy Cheung Singapore National Eye Centre
  More Information

No publications provided

Responsible Party: Samanthila Waduthantri, Clinical Research Fellow, Clinical Associate, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01647529     History of Changes
Other Study ID Numbers: R733/17/2010
Study First Received: July 19, 2012
Last Updated: January 9, 2013
Health Authority: SingHealth Centralised Institutional Review Board: Singapore

Keywords provided by Singapore National Eye Centre:
Cytomegalovirus
uveitis
endotheliitis
ganciclovir

Additional relevant MeSH terms:
Uveitis
Chorioretinitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Retinitis
Retinal Diseases
Choroiditis
Choroid Diseases
Uveitis, Posterior
Panuveitis
Iris Diseases
Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014