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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

Page last updated: August 20, 2015

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