Cytomegalovirus InfectionsPhase 4NCT02943057
Topical 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis
A Phase 4 study testing 2% guttae ganciclovir in people with Cytomegalovirus Infections, run by Singapore National Eye Centre at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- 2% guttae ganciclovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSingapore
- Study dates
- Oct 2016to 30 Nov 2024
- Phase
- Phase 4
- 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 years and older
- 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 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
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 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.
Read the 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.
- Clinical features mentioned above will be documented for activity assessment
- 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.
- Conditions
- Cytomegalovirus Infections
- Being tested
- 2% guttae ganciclovir
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% guttae ganciclovirDrug
2% guttae ganciclovir 5 times a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| 2% guttae Ganciclovir | Experimental | 2% guttae Ganciclovir 5 times a day for 6 weeks Receives: Drug: 2% guttae ganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 weeks
Secondary outcomes (1)
Clinical efficacy in clearing CMV viral load and resolution of anterior uveitis/endotheliitis following 6 weeks of treatment
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
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 posted24 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2024
- Study completion30 Nov 2024
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 InfectionsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Soon Phaik Chee, Singapore National Eye Centre
- Investigators
- SP Chee, Study chair, Singapre national eye centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943057
- Sponsor's protocol ID
- R1226/32/2015
- Status last verified
- Apr 2024
- First submitted
- 18 Oct 2016
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Waduthantri S, Zhou L, Chee SP. Aqueous humour concentration of topically applied 2.0% ganciclovir eye drops in eyes with cytomegalovirus anterior uveitis and endotheliitis. Clin Exp Ophthalmol. 2025 May-Jun;53(4):384-390. doi: 10.1111/ceo.14469. Epub 2024 Nov 25.
PubMed 39587428
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-cameral Penetration and Efficacy of Ganciclovir Following Topical Administration of 2% Ganciclovir Eye Drop for CMV Anterior Uveitis / Endotheliitis
- ClinicalTrials.gov ID
- NCT02943057
- Acronym / sponsor ID
- R1226/32/2015
- Conditions
- Cytomegalovirus Infections
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Oct 2016 (actual)
- Primary completion
- Jan 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 24 Oct 2016 (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.
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.
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.
- Clinical features mentioned above will be documented for activity assessment
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2% guttae Ganciclovir | Experimental | Drug: 2% guttae ganciclovir2% guttae Ganciclovir 5 times a day for 6 weeks |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 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
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 |
|---|---|---|
| 2% guttae ganciclovir2% guttae ganciclovir 5 times a day for 6 weeks | Drug | 2% guttae Ganciclovir |
Primary outcome
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
1 secondary outcome
Clinical efficacy in clearing CMV viral load and resolution of anterior uveitis/endotheliitis following 6 weeks of treatment
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 May 2025.
- Derived from this study: PubMed 39587428Waduthantri S, Zhou L, Chee SP. Aqueous humour concentration of topically applied 2.0% ganciclovir eye drops in eyes with cytomegalovirus anterior uveitis and endotheliitis. Clin Exp Ophthalmol. 2025 May-Jun;53(4):384-390. doi: 10.1111/ceo.14469. Epub 2024 Nov 25.
- Individual participant dataSharing planned: No
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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.
SP Chee study chair
Singapre 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 Phase 4 study testing 2% guttae ganciclovir in people with Cytomegalovirus Infections, 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 8 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 May 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 aqueous by HPLC-Mass spectrometry end of week 6 (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 NCT02943057, 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 May 2025.