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

Primary Purpose

Cytomegalovirus Anterior Segment Infection, Anterior Uveitis, Endotheliitis

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Ganciclovir
Sponsored by
Singapore National Eye Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Anterior Segment Infection focused on measuring Cytomegalovirus, uveitis, endotheliitis, ganciclovir

Eligibility Criteria

21 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Singapore National Eye Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ganciclovir

Arm Description

Treatment with topical ganciclovir ointment

Outcomes

Primary Outcome Measures

Median concentration of ganciclovir in anterior chamber and ocular surface
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

Full Information

First Posted
July 19, 2012
Last Updated
November 16, 2015
Sponsor
Singapore National Eye Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01647529
Brief Title
Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis
Acronym
Virgan
Official Title
Intra-cameral Penetration of Ganciclovir Following Topical Administration of 0.15% Ganciclovir Gel (VIRGAN©) for CMV Anterior Uveitis / Endotheliitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore National Eye Centre

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Anterior Segment Infection, Anterior Uveitis, Endotheliitis
Keywords
Cytomegalovirus, uveitis, endotheliitis, ganciclovir

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ganciclovir
Arm Type
Experimental
Arm Description
Treatment with topical ganciclovir ointment
Intervention Type
Drug
Intervention Name(s)
Ganciclovir
Intervention Description
Treatment with topical ganciclovir ointment
Primary Outcome Measure Information:
Title
Median concentration of ganciclovir in anterior chamber and ocular surface
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Correlation of intracameral concentration of virgan with the corneal thickness
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soon P Chee
Organizational Affiliation
Singapore National Eye Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gemmy Cheung
Organizational Affiliation
Singapore National Eye Centre
Official's Role
Study Chair
Facility Information:
Facility Name
Singapore National Eye Centre
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
29377953
Citation
Waduthantri S, Zhou L, Chee SP. Intra-cameral level of ganciclovir gel, 0.15% following topical application for cytomegalovirus anterior segment infection: A pilot study. PLoS One. 2018 Jan 29;13(1):e0191850. doi: 10.1371/journal.pone.0191850. eCollection 2018.
Results Reference
derived

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

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