Intra-cameral Penetration and Efficacy of Ganciclovir Following Topical Administration of 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis

R1226/32/2015

25 patients who are diagnosed with Cytomegalovirus (CMV) anterior segment infection, either uveitis or endotheliitis, will be started on 2% guttae ganciclovir, 1 drop 5 times a day for 6 weeks. Following 6 weeks of continuous application of 2% guttae ganciclovir, patient will be reviewed at the clinic within 3 hours following the last application of topical ganciclovir and clinical features will be documented for activity assessment. An aqueous sample 0.2ml is drawn. 0.1ml will be sent for RT-PCR for CMV viral load and another 0.1ml will be sent for ganciclovir drug level by HPLC method.

2016-10-01

2024-01-01

2024-09-01

Active (not recruiting)

Early phase I

25

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 any form of (topical, local or systemic) 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 (e.g. laser flare cell photometry) * Able to come for subsequent follow-up visits * Ability to provide informed consent 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 25, 'type': 'ACTUAL'}}

2024-04-24