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

Launched by SINGAPORE NATIONAL EYE CENTRE · Oct 21, 2016

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called 2% ganciclovir eye drops for patients with a type of eye infection caused by the Cytomegalovirus (CMV). Specifically, it focuses on individuals with conditions known as anterior uveitis or endotheliitis, which affect the front part of the eye. The trial will involve 25 participants who are at least 21 years old, have a confirmed CMV infection in their eye, and have not used ganciclovir treatment in the last month. Those who are currently pregnant, breastfeeding, or have certain other health conditions will not be eligible to participate.

Participants in the trial will apply the eye drops five times a day for six weeks. After this treatment period, they will visit the clinic for a check-up to assess how well the drops worked. During this visit, a small sample of fluid from their eye will be taken to measure the level of the virus and the medication. This study aims to gather information on how effective the ganciclovir eye drops are in treating CMV-related eye infections, which could help improve treatment options in the future.

Gender

ALL

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 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.