Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis
Information source: Singapore National Eye Centre
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Anterior Segment Infection; Anterior Uveitis; Endotheliitis
Intervention: Ganciclovir (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Singapore National Eye Centre Official(s) and/or principal investigator(s): Soon P Chee, Principal Investigator, Affiliation: Singapore National Eye Centre Gemmy Cheung, Study Chair, Affiliation: Singapore National Eye Centre
Overall contact: Samanthila Waduthantri, Email: samanthila.waduthantri@snec.com.sg
Summary
Objective of this study is to investigate the intracameral level of ganciclovir following
topical application of 0. 15% ganciclovir gel (VIRGANŠ) 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.
Clinical Details
Official title: Intra-cameral Penetration of Ganciclovir Following Topical Administration of 0.15% Ganciclovir Gel (VIRGANŠ) for CMV Anterior Uveitis / Endotheliitis
Study design: Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Median concentration of ganciclovir in anterior chamber and ocular surface
Secondary outcome: Correlation of intracameral concentration of virgan with the corneal thickness
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Samanthila Waduthantri, Email: samanthila.waduthantri@snec.com.sg
Singapore National Eye Centre, Singapore, Singapore; Recruiting Wei H Teng Samanthila Waduthantri, Principal Investigator Soon Phaik Chee, Principal Investigator
Additional Information
Starting date: July 2012
Last updated: January 9, 2013
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