Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Singapore National Eye Centre
• Treatments: Ganciclovir; Ganciclovir triphosphate; Ophthalmic Solutions

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 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.