Cytomegalovirus Anterior Segment InfectionVirganNCT01647529
Topical Administration of 0.15% Ganciclovir Gel for CMV Anterior Uveitis / Endotheliitis
A study testing Ganciclovir in people with Cytomegalovirus Anterior Segment Infection and Anterior Uveitis, run by Singapore National Eye Centre at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Cytomegalovirus Anterior Segment Infection, Anterior Uveitis, Endotheliitis
- What is being tested?
- Ganciclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intra-cameral Penetration of Ganciclovir Following Topical Administration of 0.15% Ganciclovir Gel (VIRGAN©) for CMV Anterior Uveitis / Endotheliitis
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.
- Being tested
- Ganciclovir
- Keywords
- Cytomegalovirus, uveitis, endotheliitis, ganciclovir
- Medical subject headings
- Uveitis, Anterior, Uveitis, Multiple Acyl Coenzyme A Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GanciclovirDrug
Treatment with topical ganciclovir ointment
| Study group | Role | What they receive |
|---|---|---|
| Ganciclovir | Experimental | Treatment with topical ganciclovir ointment Receives: Drug: Ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks
Secondary outcomes (1)
Correlation of intracameral concentration of virgan with the corneal thickness
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus Anterior Segment InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Samanthila Waduthantri, Singapore National Eye Centre
- Investigators
- Soon P Chee, Principal investigator, Singapore National Eye CentreGemmy Cheung, Study chair, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647529
- Sponsor's protocol ID
- R733/17/2010
- Acronym
- Virgan
- Status last verified
- Nov 2015
- First submitted
- 19 Jul 2012
- Last updated
- 18 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 29377953
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-cameral Penetration of Ganciclovir Following Topical Administration of 0.15% Ganciclovir Gel (VIRGAN©) for CMV Anterior Uveitis / Endotheliitis
- ClinicalTrials.gov ID
- NCT01647529
- Acronym / sponsor ID
- Virgan / R733/17/2010
- Keywords
- Cytomegalovirus, uveitis, endotheliitis, ganciclovir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 23 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ganciclovir | Experimental | Drug: GanciclovirTreatment with topical ganciclovir ointment |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GanciclovirTreatment with topical ganciclovir ointment | Drug | Ganciclovir |
Primary outcome
Median concentration of ganciclovir in anterior chamber and ocular surface
Time frame: 6 weeks
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.
1 secondary outcome
Correlation of intracameral concentration of virgan with the corneal thickness
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2015.
- Derived from this study: PubMed 29377953Waduthantri 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soon P Chee principal investigator
Singapore National Eye Centre
Gemmy Cheung study chair
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ganciclovir in people with Cytomegalovirus Anterior Segment Infection and Anterior Uveitis, run by Singapore National Eye Centre at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median concentration of ganciclovir in anterior chamber and ocular surface (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2015.