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

Anterior Uveitis Clinical Trial

— Virgan  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647529
• Other study ID #: R733/17/2010
• Status: Completed
• Phase: N/A
• First received: July 19, 2012
• Last updated: November 16, 2015
• Start date: July 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2015
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: SingHealth Centralised Institutional Review Board: Singapore
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 99 Years

Eligibility

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.

Study Design

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Uveitis
• Cytomegalovirus Anterior Segment Infection
• Endotheliitis
• Iridocyclitis
• Iritis
• Uveitis
• Uveitis, Anterior

Intervention

Drug:
• Ganciclovir
Treatment with topical ganciclovir ointment

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore National Eye Centre

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks	No
Secondary	Correlation of intracameral concentration of virgan with the corneal thickness		6 weeks	No