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

November 22, 2023 updated by: Soon Phaik Chee, Singapore National Eye Centre

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

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Detailed Description

This is non-randomised single armed prospective, cross-sectional, interventional clinical study.

25 patients who are diagnosed with Cytomegalovirus (CMV) anterior segment infection, either uveitis or endotheliitis, at the investigators clinic in Singapore National Eye Centre, 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. This will also include the patients who have never been treated with antiviral therapy and those with recurrent disease and have not had any form of ganciclovir treatment for past 1 month.

The clinical features of the active disease will be recorded in the data collection sheet and will include, documentation of the state of the cornea, KPs, AC cells, flare, flare meter reading (where possible), central corneal thickness, Intra ocular pressure (IOP) and C:D ratio.

All patients will be started on 2% guttae ganciclovir, 1 drop 5 times a day.

2% Guttae ganciclovir will be prepared from vials of ganciclovir powder for ganciclovir intravenous infusion using aseptic method.

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.

  1. Clinical features mentioned above will be documented for activity assessment
  2. Following irrigation of the conjunctival sac with 100ml of N/S to wash out any residual drug, aseptic technique is practised before 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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Singapore, Singapore
        • Singapore National Eye Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2% guttae Ganciclovir
2% guttae Ganciclovir 5 times a day for 6 weeks
2% guttae ganciclovir 5 times a day for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median concentration of ganciclovir in aqueous by HPLC-Mass spectrometry end of week 6
Time Frame: 6 weeks
Ganciclovir concentration in aqueous will be measured by HPLC-Mass spectrometry at the end of week 6
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical efficacy in clearing CMV viral load and resolution of anterior uveitis/endotheliitis following 6 weeks of treatment
Time Frame: 6 weeks
Clinical efficacy will be measured by resolution of anterior uveitis/ endotheliitis and aqueous tap negative for CMV realtime PCR at the end of week 6
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: SP Chee, Singapre national eye centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 21, 2016

First Posted (Estimated)

October 24, 2016

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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