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

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ClinicalTrials.gov Identifier: NCT02943057
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Soon Phaik Chee, Singapore National Eye Centre

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.


Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections Drug: 2% guttae ganciclovir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intra-cameral Penetration and Efficacy of Ganciclovir Following Topical Administration of 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis
Actual Study Start Date : October 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: 2% guttae Ganciclovir
2% guttae Ganciclovir 5 times a day for 6 weeks
Drug: 2% guttae ganciclovir
2% guttae ganciclovir 5 times a day for 6 weeks




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02943057


Contacts
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Contact: Samanthila Waduthantri 63228855 samanthila.waduthatri@snec.com.sg

Locations
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Singapore
Singapore National Eye Centre Recruiting
Singapore, Singapore
Contact: Samanthila Waduthantri       samanthila.waduthantri@snec.com.sg   
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
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Study Chair: SP Chee Singapre national eye centre
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Responsible Party: Soon Phaik Chee, Senior Consultant & HOD, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT02943057    
Other Study ID Numbers: R1226/32/2015
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Uveitis
Uveitis, Anterior
Iridocyclitis
Uveal Diseases
Eye Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Panuveitis
Iris Diseases
Ganciclovir
Ganciclovir triphosphate
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action