Clinical trial NCT01647529: Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis
Official title: Intra-cameral Penetration of Ganciclovir Following Topical Administration of 0.15% Ganciclovir Gel (VIRGAN©) for CMV Anterior Uveitis / Endotheliitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Anterior Segment Infection
Anterior Uveitis
Endotheliitis
Keywords: Cytomegalovirus
uveitis
endotheliitis
ganciclovir
Lead sponsor: Singapore National Eye Centre
Sponsor class: OTHER_GOV
First posted: 2012-07-23
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Median concentration of ganciclovir in anterior chamber and ocular surface
timeFrame: 6 weeks
Secondary outcomes:
measure: Correlation of intracameral concentration of virgan with the corneal thickness
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore National Eye Centre
Study officials:
affiliation: Singapore National Eye Centre
name: Soon P Chee
role: PRINCIPAL_INVESTIGATOR
affiliation: Singapore National Eye Centre
name: Gemmy Cheung
role: STUDY_CHAIR
References:
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.