Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis

NCT01647529 | Completed DMC

• 1 other identifier: R733/17/2010
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

Objective of this study is to investigate the intracameral level of ganciclovir following topical application of 0.15% ganciclovir gel (VIRGAN©) for Cytomegalovirus (CMV) anterior uveitis and endothelitis. Thirty patients who are diagnosed with CMV anterior segment infection, either uveitis or endothelitis, 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. with active CMV anterior segment infection confirmed by a positive aqueous real time PCR (RT-PCR) and have not had any form of ganciclovir treatment in the past 1 month were recruited in the study. Patients were given 0.15% ganciclovir gel 1cc 5 times a day for 6 weeks. Following 6 weeks of treatment, tears and aqueous samples will be collected. Aqueous will be sent for RT-PCR for CMV status. Ganciclovir drug level in both tears and aqueous will be measured by HPLC method. Clinically, degree of the intraocular inflammation, Intraocular pressure (IOP) and central corneal thickness (CCT) will be recorded at baseline and post-treatment.

Conditions

Cytomegalovirus Anterior Segment Infection; Anterior Uveitis; Endotheliitis

Keywords

Cytomegalovirus; uveitis; endotheliitis; ganciclovir

Outcome Measures

Primary Outcomes (1)

• Median concentration of ganciclovir in anterior chamber and ocular surface

  Following 6 weeks of continuous application of Virgan gel 0.15% 1cc 5 times a day, the patient will be reviewed at the clinic within 3 hours following the last application of the gel.

  6 weeks

Secondary Outcomes (1)

• Correlation of intracameral concentration of virgan with the corneal thickness

  6 weeks

Study Arms (1)

Ganciclovir

EXPERIMENTAL

Treatment with topical ganciclovir ointment

Drug: Ganciclovir

Interventions

Ganciclovir DRUG

Treatment with topical ganciclovir ointment

Ganciclovir

Eligibility Criteria

• Age: 21 Years - 99 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 VIRGAN or any other form of 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 (corneal pachymetry and laser flare cell photometry)
• Able to come for subsequent follow-up visits

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

Related Publications (1)

• Waduthantri S, Zhou L, Chee SP. Intra-cameral level of ganciclovir gel, 0.15% following topical application for cytomegalovirus anterior segment infection: A pilot study. PLoS One. 2018 Jan 29;13(1):e0191850. doi: 10.1371/journal.pone.0191850. eCollection 2018.

  PMID: 29377953 DERIVED

MeSH Terms

Conditions

Uveitis, Anterior; Uveitis; Multiple Acyl Coenzyme A Dehydrogenase Deficiency

Interventions

Ganciclovir

Condition Hierarchy (Ancestors)

Panuveitis; Uveal Diseases; Eye Diseases; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Mitochondrial Diseases

Intervention Hierarchy (Ancestors)

Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Soon P Chee

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

• Gemmy Cheung

  Singapore National Eye Centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow, Clinical Associate

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: July 23, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2014
• Last Updated: November 18, 2015

Record last verified: 2015-11

Locations

SG (1)