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

NCT02943057 | Completed Phase 4 DMC

• 1 other identifier: R1226/32/2015
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cytomegalovirus Infections

Outcome Measures

Primary Outcomes (1)

• Median concentration of ganciclovir in aqueous by HPLC-Mass spectrometry end of week 6

  Ganciclovir concentration in aqueous will be measured by HPLC-Mass spectrometry at the end of week 6

  6 weeks

Secondary Outcomes (1)

• Clinical efficacy in clearing CMV viral load and resolution of anterior uveitis/endotheliitis following 6 weeks of treatment

  6 weeks

Study Arms (1)

2% guttae Ganciclovir

EXPERIMENTAL

2% guttae Ganciclovir 5 times a day for 6 weeks

Drug: 2% guttae ganciclovir

Interventions

2% guttae ganciclovir DRUG

2% guttae ganciclovir 5 times a day for 6 weeks

2% guttae Ganciclovir

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore National Eye Centre

Singapore, Singapore

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• SP Chee

  Singapre national eye centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant & HOD

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 24, 2016
• Study Start: October 1, 2016
• Primary Completion: January 1, 2024
• Study Completion: November 30, 2024
• Last Updated: May 18, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)